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A randomised comparison of parecoxib versus placebo for pain management following minor day stay gynaecological surgery.

Minor gynaecological procedures such as hysteroscopy, dilatation and curettage are commonly performed in an ambulatory setting where the quality of postoperative analgesia is important in terms of patient satisfaction and the incidence of unplanned admissions. The physiology and pharmacology of nociception from uterine and cervical stimulation has not been well defined but prostaglandins, requiring the cyclo-oxygenase enzyme for synthesis, are likely to play a significant role. Prostaglandin production is blocked by non-steroidal anti-inflammatory agents (NSAID), which have a well established role in the treatment of dysmenorrhoea. Selective inhibitors of the inducible form of cyclo-oxygenase (cyclo-oxygenase-2 [COX-2]) show comparable analgesic efficacy to traditional NSAIDs for treatment of primary dysmenorrhoea (1).

NSAIDs have been shown to improve pain scores and decrease postoperative opioid use (2) following a wide variety of surgical procedures, although this may not always translate into a reduction in opioid-related side-effects (3,4). Parecoxib (Pfizer, Sydney, NSW) is a selective COX-2 inhibitor (5-7) and a prodrug which is rapidly metabolised to valdecoxib after parenteral administration (8-10). It has a rapid onset (7,9) and clinical analgesic activity for 12 to 24 hours (7,11). In comparison to traditional NSAIDs, the potential benefits of selective COX-2 inhibition include a better side-effect profile with regard to renal toxicity (12,13), gastro-intestinal irritation (7,13,14) and platelet dysfunction (14-17). Although parecoxib has been investigated across a range of surgical settings, it has not previously been evaluated for minor gynaecological surgery. This study was designed to assess the effect of the addition of parecoxib to a multimodal perioperative analgesic regimen given to women undergoing minor day stay gynaecological procedures. The null hypothesis was that there would be no difference in early postoperative pain relief between the parecoxib and placebo groups.

METHODS

After obtaining Institutional Ethics Committee approval and written informed consent, 90 women who were scheduled to undergo minor gynaecological procedures involving the uterus were recruited into this randomised, double-blind, placebo-controlled trial. Women who were of the American Society of Anesthesiologists (ASA) classification I or II and who planned to have cervical dilatation and uterine curettage, with or without hysteroscopy, were eligible for inclusion. Those with a history of renal dysfunction, hypertension, sulphonamide allergy or aged more than 70 years were excluded from the trial. Patients who were unsuitable for general anaesthesia with an inhalational agent, who required the use of suxamethonium, were taking NSAIDs or opioids preoperatively, or who received other surgical procedures, were also excluded.

Participants were recruited from the hospital day surgery unit on the day of their procedure and randomised preoperatively using a computer-generated random number sequence into one of two groups, with allocation by means of opaque sealed envelopes. Patients were also stratified on the basis of preoperative administration of misoprostol, secondary to our own anecdotal experience that this may increase postoperative pain. The study drug (parecoxib 40 mg diluted to 2 ml) and the placebo (saline 2 ml) were prepared by anaesthetic staff not involved in the study, and delivered to the attending anaesthetist in identical, unlabelled syringes. No investigator or observer was aware of the group assignment until study completion. The study solution was administered approximately 15 minutes prior to surgery. A standardised general anaesthetic technique included intravenous (IV) fentanyl 1 [micro]g/kg and propofol 1.5 to 2.5 mg/kg titrated to effect for induction, with maintenance using sevoflurane in air/oxygen and further 25 [micro]g boluses of IV fentanyl as required clinically. Prophylactic IV ondansetron 4 mg was administered and postoperative nausea and vomiting treated using a standard postoperative

protocol. Postoperative analgesia was provided using IV fentanyl 30 [micro]g every three minutes as required in the recovery area and oral or IV tramadol 100 mg, one hourly as needed, thereafter.

Preoperative data collected included patient age, weight, ASA class, Quality of Recovery (QoR) score18 the duration of anaesthesia and the type of surgical procedure. Numerical rating pain scores (0 to 10) at rest and with coughing, sedation scores and the presence of side-effects were assessed in the recovery area after arousal and at one, two and 24 hours postoperatively. Total intra- and postoperative analgesic requirements were noted. At 24 hours patients were reviewed by telephone for their recovery characteristics, using several health outcomes recovery parameters. A QoR score, which is a reliable, validated instrument for assessing quality of recovery after anaesthesia and surgery based on patient responses to questions about their well-being and functional status18, and a Modified Brief Pain Inventory questionnaire were completed19. Patients were questioned regarding the presence and severity of sedation, headache, gastric upset and nausea/vomiting.

Statistical analysis

The primary study endpoint was the dynamic pain score associated with coughing recorded in the recovery area after arousal. To detect a reduction in pain score of 2 between the two study groups, with 80% power and an alpha error of 0.05, a sample size of 37 per group was required, based on data from a similar surgical population in which the mean (SD) early pain score in a placebo group was 5 (3) (20). Pain scores and continuous data were summarised using median, interquartile range and range. Categorical data were summarised using frequency distributions. The Modified Brief Pain Inventory data were highly skewed and were analysed in discrete categories of score 0 to 3 and 4 to 10. Univariate comparisons between groups included chi-square or Fisher exact tests for categorical data and Mann-Whitney rank sum tests for continuous data. Multivariable logistic regression analysis was performed to examine the association between treatment group and dynamic pain score postoperatively. Pain was classified as more severe than 'mild' if the score was greater than 3. The covariates considered for analysis included ASA class, type of procedure, total fentanyl dose and requirement for tramadol. Covariate effects were summarised using odds ratios and their 95% confidence intervals (CI). SPSS 15.0 statistical software (SPSS Inc., Chicago, IL, USA) was used for data analysis. All hypothesis tests were two-sided and a P value <0.05 was considered significant.

RESULTS

There were 90 patients recruited to the study, with 45 subjects being randomised to each study arm. One patient from the parecoxib group was excluded from the analysis after undergoing a laparoscopic procedure. The baseline demographic and intraoperative data did not differ significantly between groups (Table 1). Administration of misoprostol preoperatively was not associated with higher dynamic pain scores following the procedure (P=0.96). There was no difference between groups for global pain score or for the area under the curve of pain scores in the recovery area (Table 2). Pain scores with coughing one hour postoperatively were significantly lower in the parecoxib group (Table 2). On multivariate analysis, after adjustment for higher scores with coughing in recovery predicting higher scores at one hour, the parecoxib group were at lower risk of moderate to severe pain (pain score >3) compared to the control group (odds ratio 0.27, 95% CI 0.08 to 0.94, P=0.040) (Table 4).

The median time from end of surgery to the first rescue dose of fentanyl did not differ between groups (Table 2). There was no difference between groups for analgesic use, including total dose of fentanyl and postoperative use of analgesics (Tables 2 and 3). At 24 hours the groups did not differ for any of the Modified Brief Pain Inventory characteristics (Table 5) or for any health recovery outcomes, including the QoR score (Table 6). The parecoxib group was less likely to experience postoperative headache than the control group (12 vs 38%, P=0.007) (Table 3), but the incidence of nausea/vomiting or gastrointestinal irritation did not differ at any assessment. Satisfaction scores were high in both groups but the median score was significantly higher in the parecoxib group, which also reported a higher incidence of complete satisfaction (78 vs 57%, P=0.042) (Table 6).

DISCUSSION

In this study, the preoperative administration of intravenous parecoxib resulted in decreased dynamic pain scores and a decreased risk of moderate to severe pain in the first hour after minor gynaecological surgery and was associated with a lower incidence of headache and greater patient satisfaction. This was despite no difference in overall analgesic use or in static and dynamic pain scores after the first postoperative hour. Overall postoperative pain scores were low in both groups and the magnitude of effect on pain from parecoxib was consequently small and of questionable clinical significance. However, the apparent impact of parecoxib on patient satisfaction is arguably a more important finding.

Prostaglandins have been identified as nociceptive mediators in somatic and visceral pain pathways, in both animal and human studies (21-23). There are central and peripheral components to the analgesic activity of NSAIDs (23,24). NSAIDs such as valdecoxib are known to provide effective analgesia when used for dysmenorrhoea1. Parecoxib has been shown to increase satisfaction and reduce opioid consumption following hysterectomy (25). Parecoxib is an effective analgesic after procedures involving skin, mucosal, muscle or bone incision, such as laparoscopy, laparotomy and dental surgery (2,9,25-29). Consequently, it might be expected that parecoxib would also produce postoperative analgesia following visceral stimulation such as occurs during cervical dilatation and curettage.

The magnitude and duration of the analgesic effect of parecoxib in the postoperative period in this population was less than that described in other trials. Previous studies have reported either an opioid dose-sparing effect or less pain for at least 12 hours postoperatively, with some studies finding benefit following a single dose of parecoxib for up to 24 hours (7,17,26). In Australia, parecoxib is licensed for a single dose but studies from other countries have evaluated multiple doses postoperatively. Parecoxib proved as efficacious as IV ketorolac 30 mg and superior to IV morphine 4 mg for pain relief following gynaecological laparotomy (7,26). After oral surgery parecoxib 40 mg shows comparable analgesic efficacy to intramuscular ketorolac 60 mg but has a longer duration of action (27). Misoprostol is a prostaglandin that is commonly administered topically to the cervix prior to gynaecological procedures, to facilitate cervical dilatation. This has the potential to increase nociceptive transduction and NSAIDs may not be as effective in the presence of exogenously supplied prostaglandin, because the cyclo-oxygenase enzyme inhibited is not responsible for the prostaglandin concentration in this setting. We anticipated that pain might be greater among women given misoprostol but found no difference in pain or other outcomes in these women.

A reduction in postoperative headache was reported by patients given parecoxib. This is consistent with a quantitative review of its efficacy and safety, which found the risk ratio for headache was significantly reduced (risk ratio 0.68; 95% CI 0.48 to 0.97) (31). NSAIDs have been extensively investigated as analgesics to treat headache, in particular migraine. The exact mechanism for this effect remains to be elucidated (32).

There has been concern about the cardiovascular complications associated with selective COX-2 inhibitors. This followed the results of trials in patients undergoing coronary artery bypass surgery, in which an increased risk of major cardiovascular events was noted (33,34). These studies are likely to reflect a class effect of NSAIDs rather than being specific to COX-2 inhibitors (35). Following surgery other than cardiothoracic surgery, an increase in risk of adverse cardiovascular events has not been demonstrated (35,36). Licensed use of parecoxib in Australia remains restricted to single dose for postoperative analgesia, despite evidence of a good safety profile in populations at low risk of cardiovascular disease.

This study has several limitations. It was powered on an anticipated dynamic pain score of 5 in the placebo control group, a figure based on previous studies in a similar population (20). However, the median pain scores in the control group in this study were much lower at all time points postoperatively, decreasing the power to demonstrate a significant benefit from parecoxib. Of note we did not probe the reasons behind a higher level of satisfaction in the parecoxib group. This may have been due to the modest decrease in early postoperative pain and the lower incidence of headache, or irrespective of the use of validated instruments for recovery characteristics and health outcomes, other unknown factors.

In conclusion, in this study it was found that the preoperative administration of IV parecoxib 40 mg was associated with a small but statistically significant decrease in early dynamic pain scores and an apparent improvement in patient satisfaction. Given its relatively low cost, we consider that the addition of IV parecoxib to a multimodal analgesic regimen for minor day stay gynaecological procedures can be supported on the basis of the modest advantages identified. Future studies should further explore the apparent improvement in satisfaction and examine whether even cheaper analgesics, such as paracetamol, have similar benefits.

ACKNOWLEDGEMENTS

This authors wish to thank our study coordinators, research midwives Desiree Cavill and Tracy Bingham. The authors also wish to thank the nursing staff of the recovery room and day surgery unit for their assistance in completing the study.

Accepted for publication on June 9, 2009.

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(17.) Bajaj P, Ballary CC, Dongre NA, Baliga VP, Desai AA. Role of parecoxib in pre-emptive analgesia: comparison of the efficacy and safety of pre- and postoperative parecoxib in patients undergoing general surgery. J Indian Med Assoc 2004; 102:272, 274, 276-278.

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(20.) Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand 2000; 44:873-877.

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(23.) Shin S-W, Sandner-Kiesling A, Eisenach JC. Systemic, but not intrathecal ketorolac is antinociceptive to uterine cervical distension in rats. Pain 2003; 105:109-114.

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(25.) Niruthisard S, Werawataganon T, Bunburaphong P, Ussawanophakiat M, Wongsakornchaikul C, Toleb K. Improving the analgesic efficacy of intrathecal morphine with parecoxib after total abdominal hysterectomy. Anesth Analg 2007; 105:822-824.

(26.) Bikhazi GB, Snabes MC, Bajwa ZH, Davis DJ, LeComte D, Traylor L et al. A clinical trial demonstrates the analgesic activity of intravenous parecoxib sodium compared with ketorolac or morphine after gynecologic surgery with laparotomy. Am J Obstet Gynecol 2004; 191:1183-1191.

(27.) Daniels SE, Grossman EH, Kuss ME, Talwalker S, Hubbard RC. A double-blind, randomized comparison of intramuscularly and intravenously administered parecoxib sodium versus ketorolac and placebo in a post-oral surgery pain model. Clin Ther 2001; 23:1018-1031.

(28.) Malan TP Jr, Gordon S, Hubbard R, Snabes M. The cycloox ygenase-2-specific inhibitor parecoxib sodium is as effective as 12 mg of morphine administered intramuscularly for treating pain after gynecologic laparotomy surgery. Anesth Analg 2005; 100:454-460.

(29.) Joshi GP, Viscusi ER, Gan TJ, Minkowitz H, Cippolle M, Schuller R et al. Effective treatment of laparoscopic cholecystectomy pain with intravenous followed by oral COX-2 specific inhibitor. Anesth Analg 2004; 98:336-342.

(30.) Mehlisch DR, Desjardins PJ, Daniels S, Hubbard RC. Single doses of parecoxib sodium intravenously are as effective as ketorolac in reducing pain after oral surgery. J Oral Maxillofac Surg 2003; 61:1030-1037.

(31.) Kranke P, Morin AM, Roewer N, Eberhart LH. Patients' global evaluation of analgesia and safety of injected parecoxib for postoperative pain: a quantitative systematic review. Anesth Analg 2004; 99:797-806.

(32.) Suthisisang C, Poolsup N, Kittikulsuth W, Pudchakan P, Wiwatpanich P. Efficacy of low-dose ibuprofen in acute migraine treatment: systematic review and meta-analysis. Ann Pharmacother 2007; 41:1782-1791.

(33.) Aldington S, Shirtcliffe P, Weatherall M, Beasley R. Increased risk of cardiovascular events with parecoxib/valdecoxib: a systematic review and meta-analysis. N Z Med J 2005; 118:U1755.

(34.) Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005; 352:1081-1091.

(35.) Schug SA, Joshi GP, Camu F. Parecoxib--getting to the heart of the matter. Anaesthesia 2007; 62:291-292.

(36.) Schug SA, Joshi GP, Camu F, Pan S, Cheung R. Cardiovascular safety of the cyclooxygenase-2 selective inhibitors parecoxib and valdecoxib in the postoperative setting: an analysis of integrated data. Anesth Analg 2009; 108:299-307.

Address for correspondence: Dr N. McDonnell, Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Rd, Subiaco, WA 6008. Email: Nolan.McDonnell@health.wa.gov.au

K. S. LUSCOMBE *, N. J. McDONNELL ([dagger]), N. A. MUCHATUTA ([double dagger]), M. J. PAECH ([section]), E. A. NATHAN **

Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, Perth, Western Australia, Australia

* M.B., B.S., F.A.N.Z.C.A., Staff Specialist.

([dagger]) B.H.B., M.B., Ch.B., F.A.N.Z.C.A., Staff Specialist.

([double dagger]) B.Sc., M.B., B.S., F.R.C.A., Research Fellow.

([section]) M.B., B.S., D.R.C.O.G., F.R.C.A., F.A.N.Z.C.A., F.F.P.M.A.N.Z.C.A., F.R.A.N.Z.C.O.G. (Hon), D.M., Professor of Obstetric Anaesthesia, Pharmacology and Anaesthesiology Unit, School of Medicine and Pharmacology, The University of Western Australia.

** B.Sc., Biostatistician, Women and Infants Research Foundation.
Table 1
Demographic and intraoperative data

                      Control group     Parecoxib group   P value
                      (n = 45)          (n=45)

Age (y)               35                34                0.487
                      (29-41; 19-58)    (32-43; 22-59)
Weight (kg)           63                67                0.120
                      (55-72; 42-106)   (60-75; 44-103)
QoR score             17                17                0.771
                      (16-18; 11-18)    (16-18; 13-18)
ASA class II          11 (24%)          5 (11%)           0.098
Preoperative pain     0 (0-2; 0-8)      0 (0-2; 0-7)      0.848
score
Surgical procedure
  Dilatation and      38 (84%)          33 (73%)          0.197
  curettage

  Evacuation of       7 (16%)           12 (27%)
  retained products
  of conception

Preoperative          21 (46.7%)        19 (42.2%)        0.671
misoprostol

Duration of surgery   12 (8-17; 4-30)   10 (9-15; 4-40)   0.715
(min)
Fentanyl dose         100               90                0.308
([micro]g)            (75-100;          (75-100; 0-150)
                      50-150)

Data represented as median (interquartile range; range) or n
(%) as appropriate. QoR = Quality of Recovery score (range 0
to 18), ASA=American Society of Anesthesiologists physical
classification status.

Table 2
Outcomes during recovery

                                                  Control group
                                                  (n=45)

Analgesics

  Postoperative fentanyl                           14 (33%)
    Dose ([micro]g)                                95 (60-100; 40-100)
  Time from end of surgery                         26 (20-32; 10-58)
    to postoperative
    fentanyl (min)
  Total dose fentanyl                             100 (75-155; 50-300)
    ([micro]g)

  Postoperative tramadol use                        8 (18%)
    Tramadol dose (mg)                             95 (50-100; 50-100)
  Postoperative antiemetic                          2 (5%)

Pain scores
  Global
                               Recovery             2 (0-6; 0-10)
                               area

                               1 h                  2 (0-4; 0-9)
                               2 h                  0 (0-2; 0-9)
                               24 h                 1 (0-3; 0-6)

  Dynamic with cough

                               Recovery             2 (0-5; 0-10)
                               area

                               1 h                  2 (0-4; 0-9)
                               2 h                  1 (0-2; 0-9)
                               24 h                 0 (0-3; 0-9)

  AUC (dynamic pain scores)
                               [less than           1.5 (0.5-4.4;
                               or equal to] 1 h     0-8.5)

                               [less than           3 (1-7.5; 0-17.5)
                               or equal to] 2 h

  Pelvic pain
                               Recovery             2 (0-5; 0-10)
                               area

                               1 h                  2 (0-4; 0-9)
                               2 h                  0 (0-2; 0-9)

  Pain 0-24 h                  None                20 (48%)
                               Mild                16 (38%)
                               Moderate             6 (14%)

Post recovery room
  analgesic use

  Any                                              20 (48%)
  Paracetamol                                      13 (31%)
  NSAID                                             7 (17%)
  Tramadol                                          3 (7%)

                                                  Parecoxib
                                                  group (n=44)

Analgesics

  Postoperative fentanyl                           13 (30%)
    Dose ([micro]g)                                60 (35-100; 30-200)
  Time from end of surgery                         20 (13-34; 3-51)
    to postoperative
    fentanyl (min)
  Total dose fentanyl                             100 (75-129; 0-270)
    ([micro]g)

  Postoperative tramadol use                        6 (14%)
    Tramadol dose (mg)                            100 (88-100; 50-100
  Postoperative antiemetic                          1 (2%)

Pain scores
  Global
                               Recovery             2 (0-4; 0-8)
                               area

                               1 h                  1 (0-3; 0-8)
                               2 h                  0 (0-2; 0-8)
                               24 h                 1 (0-3; 0-8)

  Dynamic with cough

                               Recovery             2 (0-4; 0-10)
                               area

                               1 h                  0 (0-3; 0-6)
                               2 h                  0 (0-2; 0-5)
                               24 h                 0 (0-1; 0-8)

  AUC (dynamic pain scores)
                               [less than         1.5 (0-4.0; 0-6.5)
                               or equal to] 1 h

                               [less than         2.5 (1-7.0; 0-9.5)
                               or equal to] 2 h

  Pelvic pain
                               Recovery             2 (0-4; 0-10)
                               area

                               1 h                  0 (0-3; 0-6)
                               2 h                  0 (0-2; 0-7)

  Pain 0-24 h                  None                20 (49%)
                               Mild                17 (42%)
                               Moderate             4 (10%)

Post recovery room
  analgesic use

  Any                                              15 (37%)
  Paracetamol                                       9 (22%)
  NSAID                                             5 (12%)
  Tramadol                                          1 (2%)

                                                  P value

Analgesics

  Postoperative fentanyl                          0.816
    Dose ([micro]g)                               0.185
  Time from end of surgery                        0.296
    to postoperative
    fentanyl (min)
  Total dose fentanyl                             0.463
    ([micro]g)

  Postoperative tramadol use                      0.592
    Tramadol dose (mg)                            0.252
  Postoperative antiemetic                        1.000

Pain scores
  Global
                               Recovery           0.631
                               area

                               1 h                0.279
                               2 h                0.755
                               24 h               0.434

  Dynamic with cough

                               Recovery           0.840
                               area

                               1 h                0.037
                               2 h                0.445
                               24 h               0.267

  AUC (dynamic pain scores)
                               [less than         0.387
                               or equal to] 1 h

                               [less than         0.401
                               or equal to] 2 h

  Pelvic pain
                               Recovery           0.601
                               area

                               1 h                0.091
                               2 h                0.427

  Pain 0-24 h                  None               0.811
                               Mild
                               Moderate

Post recovery room
  analgesic use

  Any                                             0.309
  Paracetamol                                     0.353
  NSAID                                           0.562
  Tramadol                                        0.616

Data represented as median (interquartile range; range) or n (%) as
appropriate. AUC=area under the curve,
NSAID=non-steroidal anti-inflammatory drug.

Table 3
Postoperative adverse effects

                              Control group    Parecoxib group   P
                              (n=45)           (n=44)            value

Sedation score
                   Recovery    5 (2-7; 0-10)   4 (0-7; 0-9)      0.646
                   area

                   1 h         2 (0-5; 0-10)   1 (0-5; 0-10)     0.305
                   2 h         0 (0-2; 0-8)    1 (0-2; 0-10)     0.330

PONV

  Nausea only      PACU        4 (9%)          1 (2%)            0.187

                   1 h         3 (7%)          1 (2%)            0.617
                   2 h         4 (9%)          1 (3%)            0.366
                   24 h        9 (21%)         5 (12%)           0.261

  Vomiting         1 h         -               1 (2%)            1.000
                   24 h        -               2 (5%)            0.494

  Postoperative                2 (5%)          1 (2%)            1.000
    antiemetic

Gastrointestinal
irritation
                   Recovery    -               1 (2%)            0.488
                   area

                   1 h         -               -
                   2 h         2 (5%)          1 (3%)            1.000
                   24 h        1 (2%)          -                 1.000
Headache
                   Recovery    2 (5%)          2 (5%)            1.000
                   area

                   1 h         3 (7%)          2 (5%)            1.000
                   2 h         2 (5%)          5 (14%)           0.234
                   24 h       16 (38%)         5 (12%)           0.007

Data represented as median (interquartile range; range) or n (%) as
appropriate. PONV=postoperative nausea and
vomiting, PACU=post anaesthesia care unit.

Table 4
Predictors of pain score >3 with coughing at one hour
postoperatively

                        OR      95% CI       P value

Recovery area
  score [less than or   1.00
    equal to] 3
  score >3              11.11   3.33-37.14   <0.001

Group
  control               1.00
  parecoxib             0.27    0.08-0.94    0.040

OR=odds ratio, CI=confidence interval.

Table 5
Modified Brief Pain Inventory (MBPI-SF)

                                   Control     Parecoxib   P value
                                   group       group
                                   (n=42)      (n=41)

MBPI-SF

  Any pain last 24 h                22 (52%)    20 (49%)    0.743
  Worst pain 24 h          0-3      27 (64%)    26 (65%)    0.946
                           4-10     15 (36%)    14 (35%)
  Least pain 24 h          0-3      42 (100%)   39 (97%)    0.488
                           4-10     --           1 (3%)
  Average pain 24 h        0-3      34 (81%)    37 (92%)    0.125
                           4-10      8 (19%)     3 (8%)
  Pain now                 0-3      38 (90%)    38 (95%)    0.676
                           4-10      4 (10%)     2 (5%)
  Relief after             0-30%     1 (3%)      2 (7%)     0.600
    medication (%)

                          40-100%   31 (97%)    27 (93%)
Pain interfering
with
  Activity                 0-3      34 (81%)    35 (85%)    0.591
                           4-10      8 (19%)     6 (15%)
  Mood                     0-3      37 (88%)    35 (85%)    0.714
                           4-10      5 (12%)     6 (15%)
  Walking                  0-3      39 (93%)    38 (93%)    1.000
                           4-10      3 (7%)      3 (7%)
Relations with people      0-3      40 (95%)    39 (95%)    1.000
                           4-10      2 (5%)      2 (5%)
  Sleep                    0-3      38 (91%)    38 (93%)    1.000
                           4-10      4 (10%)     3 (7%)
  Coughing                 0-3      39 (93%)    39 (95%)    1.000
                           4-10      3 (7%)      2 (5%)
  Deep breathing           0-3      39 (93%)    40 (98%)    0.616
                           4-10      3 (7%)      1 (2%)
  Concentration            0-3      40 (95%)    36 (88%)    0.265
                           4-10      2 (5%)      5 (12%)

Data represented as n (%) as appropriate.

Table 6
Health recovery survey in the last 24 hours

                          Control group   Parecoxib              P
                          (n=43)          group (n=41)           value
Pain
  Any pain 24 h            34 (79%)        30 (73%)              0.526
  Sleep disturbed           6 (14%)         2 (5%)               0.265
    by pain
  Awake due to pain         8 (19%)         4 (10%)              0.229

Nausea/vomiting
  Any nausea 24 h           8 (19%)         5 (12%)              0.417
  Any vomiting 24 h       --                2 (5%)               0.235
  Any medication 24 h       1 (2%)          2 (5%)               0.611
  Any of above              8 (19%)         5 (12%)              0.417

Food and drink
  Normal solids/liquids    32 (74%)        28 (68%)              0.466
  Light solids/liquids     10 (23%)        13 (32%)
  Liquids only              1 (2%)        --

Voiding
  Normal as                40 (93%)        41 (100%)             0.241
    preoperatively
  Unable to void/           3 (7%)        --
    new symptoms
Bowel function
  Normal function          25 (58%)        30 (73%)              0.148
    (preoperative)
  Unable to move bowels    18 (42%)        11 (27%)

Activity
  Normal/light             14 (33%)        16 (39%)              0.344
  Light/home only          18 (42%)        11 (27%)
  Passive/sleeping         11 (26%)        14 (34%)
  % at full activity       60 (50-90;      60 (30-90; 0-100)     0.489
                           10-100)

Quality of recovery        17 (16-18;      18 (17-18; 13-18)     0.145
                           12-18)
Completely satisfied       24 (57%)        32 (78%)              0.042
  (100% satisfaction
  score)
Satisfaction              100 (90-100;    100 (100-100; 10-100   0.043
                          40-100)

Data represented as median (interquartile range; range) or n (%)
as appropriate.
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Article Details
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Author:Luscombe, K.S.; McDonnell, N.J.; Muchatuta, N.A.; Paech, M.J.; Nathan, E.A.
Publication:Anaesthesia and Intensive Care
Article Type:Report
Geographic Code:8AUST
Date:Jan 1, 2010
Words:4790
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