Effect of rectal acetaminophen with intravenous opioid on comfort levels and opioid use in full-term infants post-open heart repair.
Providing pharmacologic combination therapy to achieve maximum analgesic benefit with minimal to no side effect at the lowest effective dose should be the standard of practice and basis for implementation of protocols for pediatric patients with postoperative pain management needs (Chiaretti et al., 2013; Kokinsky & Thornberg, 2003; Rosero & Joshi, 2014; Verghese & Hannallah, 2010). However, managing pain effectively in pediatric patients postoperatively poses unique challenges and quandaries for providers and caregivers alike. Acute pain needs coupled with potential postsurgical complications, including bleeding, fluid shifts, and hemodynamic instability, lend themselves to judicious use of analgesics in the postoperative setting.
A review of the literature demonstrates that rectal acetaminophen used as an analgesic adjunct with IV opioids has opioid-sparing effects that decrease overall opioid consumption and improve comfort levels. A review of the literature demonstrating accurate measurement and assessment of comfort levels in infants can be accomplished by the use of ageappropriate pain assessment and measurement tools is also described.
Double-Blind Randomized Controlled Clinical Trials
Korpela, Korvenoja, and Meretoja (1999) randomized 120 children (ages 1 to 7 years) to receive placebo, 20 mg/kg, 40 mg/kg, or 60 mg/kg doses of rectal acetaminophen after anesthetic induction for an elective daycase surgical procedure. A statistically significant finding (p < 0.001) demonstrated that dose-dependent acetaminophen (35.4 mg/kg) had an opioid-sparing effect on 50% of the children in the PACU (Korpela et al., 1999). Improved comfort levels were demonstrated by documentation and interpretation of behavioral assessment and physiologic measurements, which were then rendered a score on a visual analog scale (VAS). Decreased overall morphine consumption was demonstrated in children who received 40 mg/kg and 60 mg/kg doses of rectal acetaminophen.
Dashti, Amini, and Zanguee (2009) recruited 104 children (ages 7 to 15 years) for randomization to receive placebo or 40 mg/kg dosing of rectal acetaminophen after anesthetic induction for adenotonsillectomy. There was a statistically significant finding (p < 0.002) in regard to comfort levels in the acetaminophen group upon arrival to the PACU and at 2 hours, 4 hours, and 6 hours post-procedure. Patients who received acetaminophen had less pain by report, a 62% opioid dose-sparing effect, and were more comfortable based on VAS pain scores than the placebo group (Dashti et al., 2009).
A total of 160 children (ages 1 to 6 years) undergoing adenoidectomy with or without myringotomy were randomized to receive either 40 mg/kg per dose of rectal acetaminophen, 15 mg/kg per dose of rectal ibuprofen, a combination of both, or placebo after anesthetic induction. After controlling for variables between participants, opioid-sparing was statistically significant for study groups inclusive of acetaminophen (p < 0.03), ibuprofen (p < 0.001), and combination (p < 0.002) (Viitanen, Tuominen, Vaaraniemi, Nikanne, & Annila, 2003). Opioid consumption was highest in the placebo group (p < 0.008). Pain scores were similar in the acetaminophen and ibuprofen groups using the Objective Pain Scale (Viitanen et al., 2003).
Capici et al. (2008) compared intravenous acetaminophen to rectal acetaminophen and its postoperative effect on the duration of analgesia (first analgesic request) and comfort levels in children post-adenotonsillectomy. Participants either received 15 mg/kg IV acetaminophen or 40 mg/kg of rectal acetaminophen after anesthetic induction. The time to first analgesic request was longer in participants who received rectal acetaminophen (10 hours) versus those participants who received the IV formulation (7 hours) (p < 0.01). Children who received rectal acetaminophen had a 78% global comfort score of 4 or less as documented by The Children and Infants Postoperative Pain Scale (CHIPPS) versus 61% of children who received IV acetaminophen (Capici et al., 2008).
In 2014, Haddadi et al. compared the effectiveness of IV versus rectal acetaminophen on controlling pain in post-adenotonsillectomy patients. Ninety-six children (ages 4 to 10 years) were randomized to receive either IV acetaminophen 10 mg/kg or rectal acetaminophen 15 mg/kg after anesthetic induction. Forty-three percent of children who received rectal acetaminophen reported no pain immediately postoperatively as compared to 10% of patients in the IV acetaminophen group as documented by the CHIPPS scoring criteria. Postoperative pain scores at 4-hour and 6-hour post-procedure were lower in children who received rectal acetaminophen versus IV acetaminophen (p < 0.05). Rescue analgesic post-procedure was less in the rectal acetaminophen group than in the IV formulation group (p < 0.0001) (Haddadi et al., 2014).
Measurement and Assessment Of Comfort in Infants
The VAS is a well-researched and validated pain assessment tool used with adults and children. The empirical literature demonstrates that accurate measurement of comfort levels in infants can be accomplished without the use of the VAS by using other more age-appropriate pain assessment tools. Franck, Ridout, Howard, Peters, and Honour (2010) compared indices of pain in 81 critically ill newborns for 48 hours post-cardiac surgery. Physiologic parameters, urine, and serum cortisol levels were compared using four separate pain measurement scales (Premature Infant Pain Profile [PIPP], COMFORT Scale, CHIPPS, and CRIES [Crying; Requires increased oxygen administration; Increased vital signs; Expression; Sleeplessness]).
The COMFORT pain assessment tool produced a 27% score difference between procedures causing pain and those that did not (p < 0.001) (Franck et al., 2010). Of all pain indices studied, the COMFORT pain assessment tool was the most accurate in identifying pain needs in critically ill newborns (Franck et al., 2010).
McNair, Ballantyne, Dionne, Stephens, and Stevens (2004) compared the validity of the PIPP and CRIES pain assessment scales to the VAS in the first 72 hours immediately after surgery using a prospective, correlational-observational design study. Pain was assessed in 51 neonates (ages 28 to 42 weeks). The intraclass correlation profiles revealed moderate correlation between assessment scales (correlation value = 0.62) until 24 hours postoperatively (McNair et al., 2004). This study supports the CRIES and PIPP scales as valid measurements of pain in term and preterm neonates. Data from this study also support comparable efficacy and accuracy of the CRIES and PIPP scales to the well-researched VAS measurement tool (McNair et al., 2004).
In a prospective, single correlational-observational design study, Hummel, Puchalski, Creech, and Weiss (2007) examined the clinical reliability and validity of the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) in neonates who were mechanically ventilated with prolonged pain. Forty-six infants (ages 23 to 40 weeks) were observed for a total of 46 observations. Comparison of the N-PASS to the PIPP for correlation, internal consistency, and construct validity was measured. Based on Spearman's rank (correlational coefficient) of 0.83, Cronbach's alpha of 0.82 and 0.87, and Wilcox signed-rank test (p < 0.001), the N-PASS is a reliable pain/agitation assessment tool for post-operative infants (ages 23 weeks and older) (Hummel et al., 2007).
Voepel-Lewis, Zanotti, Dammeyer, and Merkel (2010) evaluated the FLACC pain assessment tool for accuracy and validity in children before analgesic administration and during painful procedures. They compared the FLACC tool's efficacy and correlational relativity to the 0 to 10 Numerical Pain Rating and COMFORT scales, respectively. FLACC scores reported indicated a highly correlational relationship with the 0 to 10 and COMFORT pain scales values (p = 0.963 and p = 0.849) (VoepelLewis et al., 2010). Cronbach's alpha supported excellent internal consistency 0.882 with excellent interrater reliability expressed by correlation coefficients of 0.67 to 0.95 (VoepelLewis et al., 2010).
Bai, Hsu, Tang, and van Dijk (2012) piloted a repeated-observation study examining specificity, sensitivity, and validity of the VAS, COMFORT, and FLACC pain scales in postoperative pediatric cardiothoracic surgical patients (ages 0 to 7 years). One hundred and seventy children were assessed with the FLACC and COMFORT pain scales over a three-day period. The FLACC pain assessment and measurement tool showed the highest sensitivity (98%) and strong specificity (88%) as compared to the COMFORT pain assessment tool (sensitivity 86% and specificity 83%) (Bai et al., 2012).
After reviewing the empirical literature for evidence of a relationship between IV opioids and adjuvant use of rectal acetaminophen as an opioid-sparing analgesic combination that decreases overall opioid exposure and improves comfort levels, research studies that corroborated these findings were identified. Further examination of the empirical literature supported that pain assessment and measurement can be accurately and reliably documented in premature and term newborn infants using well-established, reliable, and valid pain assessment and measurement scales. Several pain assessment and measurement scales currently exist that consistently and accurately assess pain in premature and term newborns. These include the COMFORT, CRIES, PIPP, N-PASS, VAS, and FLACC scales.
Objective and Aims
The overall objective of this study was to compare comfort levels and overall opioid use among two groups of full-term infants with congenital heart defect (CHD) within 24 hours or less post-open heart repair; one group received rectal acetaminophen in conjunction with IV opioid, and the other group received IV opioid alone. One specific aim of this study was to accurately identify, document, and analyze comparison findings specific to comfort levels and overall opioid use in fullterm infants with CHD post-open heart repair who received rectal acetaminophen in conjunction with IV opioid versus IV opioid alone. An additional aim was to stimulate development and implementation of a practice change protocol or clinical pathway.
This retrospective, 18-month, quantitative study was conducted at a large urban children's teaching hospital using electronic medical chart review after Institutional Review Board (IRB) approval.
The FLACC Behavioral Pain Assessment scores between participant groups were compared to determine statistical significance between the two groups. In a systematic review of measurement instruments used to identify and quantify pain, distress, analgesic, and sedation adequacy in critically ill pediatric patients, Dorfman, Sumamo
Schelenberg, Rempel, Scott, & Hartling (2014) identified the modified FLACC scale as one of the most applicable pain rating scales available for assessment and measurement of pain in pediatric patients.
It was determined that 100 participants (50 in each group) would provide power set at 80%, and a two-sided significance level at 0.05 would yield the probability of 0.66 that an observation in group one (the acetaminophen and opioid combination group) was less than an observation in group two (the opioid only group) using a Wilcoxon rank-sum test. A two-sided, independent samples t-test with a sample of 50 in each group would need a 50% power to detect a 40% reduction in opioid use assuming the coefficient of variation is one.
Inclusion criteria. All full-term infants with CHD (36 weeks or greater gestation as of the date of surgery) who were less than or equal to 30 days of age and who a) underwent open-heart repair within 24 hours or less, b) received IV opioids (both comparison groups), and c) received rectal acetaminophen (test of change group) between November 1, 2012, and April 29, 2014, were included.
Exclusion criteria. Participants who met the following conditions were excluded from the study: a) received or were receiving any mechanical support device inclusive of extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), or right ventricular assist device (RVAD); b) received or were receiving paralytic agents, benzodiazepines, dexmedetomidine, propofol, ketamine, barbiturates, antiepileptics, antidepressant, or received IV or oral acetaminophen within 24 hours or less post open heart repair; c) participants with known or acquired neurologic, hepatic, or renal insufficiency; or d) those who had a known allergy to or intolerance of acetaminophen or opioid. Renal insufficiency was defined as an equal to or greater than 25% increase from baseline creatinine post-operatively (Gelot & Nakhla, 2014).
Existing operative records located within cardiac-specific databases identified infants who underwent open-heart repair in the specified time frame. Access to existing medical records was obtained after IRB review and approval of the proposed study. Retrospective chart reviews were completed with the following data recorded: demographic data, pain score(s), serum creatinine(s) and medication(s) administered, and timeframe. Total participant opioid requirement in 24 hours post-open heart repair was converted into morphine equivalents for comparison. For example, if a participant received fentanyl, the average hourly amount administered in mcg/hour was multiplied by 60 (potency ratio, ranges from 10 to 100:1 fentanyl to morphine) to obtain the equipotent IV morphine dose administered every 4 hours. This value was then multiplied by 6 to ascertain the equivalent daily morphine dose (Meyer & Berens, 2001).
The FLACC Behavioral Pain Assessment scores for the two study groups were compared using independent samples t-tests. Total milligrams per kilogram of opioid administered over a 24-hour period were compared using Wilcoxon rank-sum test. For comparison of demographic data, mean and standard deviation were reported for continuous variables. Count and frequency were reported for categorical variables. Two sample t-tests were used to compare continuous variables, and Fisher's exact tests were used to compare the categorical variables.
A total of 203 participants were identified as meeting inclusion criteria. Nine patients were excluded due to
Several pain assessment and measurement scales currently exist that consistently and accurately assess pain in premature and term newborns. lack of documented pain scores, 93 patients were excluded due to exposure to confounding variables including additional medications with analgesic properties or sedative medications, 7 patients were excluded due to need for mechanical support, and 20 patients were excluded due to poor postoperative creatinine clearance. Thus, a total of 74 participants were included and were compared for comfort levels and overall opioid exposure within 24 hours or less post-open heart repair.
In total, 53 infants received rectal acetaminophen in conjunction with IV opioid, and 21 infants received IV opioid only. Comparison of demographic and clinical variables between the two participant groups queried identified no clinically significant variance (see Table 1). Comparison of overall opioid exposure between the two participant groups identified a statistically significant difference (p < 0.01) between infants who received rectal acetaminophen in conjunction with IV opioid versus infants prescribed IV opioid alone (see Table 2). The median value of opioid usage was 0.28 mg/kg/day in infants who received IV opioid only versus 0.11 mg/kg/day in infants who received rectal acetaminophen with IV opioid in the first 24 hours post-open heart repair. The average dose of rectal acetaminophen received in 24 hours postopen heart repair was 45 mg/kg/day.
Comparison of pain scores using the FLACC Behavioral Pain Assessment Scale between the two participant groups studied did not identify a statistically significant difference (p < 0.08) in comfort levels between infant groups within the first 24 hours postopen heart repair (see Figure 1).
Pediatric cardiothoracic surgical patients experience varying degrees of pain in the immediate postoperative period. Multimodal pain management therapies have been found to optimize pain needs in postoperative patients (Manworren, 2015). This retrospective study compared comfort level scores using the FLACC Behavioral Pain Assessment Scale and overall opioid use in full-term infants with CHD who were 30 days of age or younger and within 24 hours or less post-open heart repair. Fifty-three infants received rectal acetaminophen in conjunction with IV opioid, and 21 infants received IV opioid only. Study participants were limited due to exposure to confounding variables, lack of documented pain scores, need for mechanical support postoperatively, and poor postoperative creatinine clearance. Nonetheless, some results were significant as reported. Infants who received IV opioid alone used more opioid overall, with a concomitant increase in overall opioid exposure than infants who received standardly prescribed rectal acetaminophen with IV opioid in the first 24 hours post-open heart repair. However, there was no reported statistically significant difference in comfort levels between both groups.
An additional limitation of this study was the lack of generalizability or external validity of data findings due to limited sampling from a single investigative site. Findings should be replicated or reproduced under similar conditions in related populations for generalizability of data findings to be applicable. A further identified limitation of this study was selective participant population. Examining alternative infant participant populations and comparing comfort levels and overall opioid use in these study groups postoperatively may add to the body of knowledge this study provided.
A final limitation of this study may be the designated time period of study. By limiting the period of study to 18 months, identification of a statistically significant difference in comfort levels between participant groups may have been recognized.
Implications for Practice
Based on this study's results, future practice recommendations would include supporting adjuvant use of rectal acetaminophen with IV opioid to reduce overall opioid exposure postoperatively in infants postopen heart repair. Reduced opioid exposure may lead to fewer mu-mediated side effects, such as constipation, nausea and vomiting, dizziness, mental confusion, and respiratory depression (Rafiq et al., 2014). Shorter recovery times and hospital stays, along with reduced healthcare-associated costs, may result from decreased overall opioid use and concomitant mumediated side effects. Of note, the use of a multi-modal pain management approach post-cardiac surgery has shown to be a more effective pain management strategy than monotherapy to improve comfort levels and decrease mu-mediated side effects (Rafiq et al., 2014).
Additional recommendations would include using lipophilic emulsion composition of suppositories for superior absorption (Lakshmi, Deepthi, & Rama, 2012). Dosing recommendations for rectal acetamino phen at 40 mg/kg/dose have demonstrated an improvement in comfort levels and decreased overall morphine consumption in children postoperatively (Capici et al. 2008; Dashti et al., 2009; Korpela et al., 1999).
Additional practice recommendations would include clinical pathway development and implementation of practice change protocols that incorporate not only adjuvant use of rectal acetaminophen with IV opioid postoperatively in infants, but use of valid and accurate pain assessment tools in the postoperative period. The FLACC pain assessment and measurement tool has shown the highest sensitivity (98%) and specificity (88%) as compared to the COMFORT pain assessment tool (sensitivity 86% and specificity 83%) (Bai et al., 2012) in pediatric patients. Frequent and accurate pain assessment and measurement in pediatric patients would potentiate timely intervention of analgesic need and patient response improving patient care and patient care outcomes.
A final recommendation would be a multi-center study trial replicating this study or studying alternative or selective infant populations with
CHD to determine if adjuvant use of rectal acetaminophen with IV opioid as compared to IV opioid-only improves comfort levels and decreases overall opioid use and exposure in infants post-open heart repair.
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Dashti, G.A., Amini, S., & Zanguee, E. (2009). The prophylactic effect of rectal acetaminophen on postoperative pain and opioid requirements after adenotonsillectomy in children. Middle East Journal of Anesthesia, 20(2), 245-249.
Dorfman, T.L., Sumamo Schelenberg, E., Rempel, G.R., Scott, S.D., & Hartling, L. (2014). An evaluation of instruments for scoring physiological and behavioral cues of pain, non-pain related distress, and adequacy of analgesia and sedation in pediatric mechanically ventilated patients: A systematic review. International Journal of Nursing Studies, 51(4), 654-676.
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Jacqueline M. Ochsenreither, DNP, RN, CRNP, PPCNP-BC, is Director, The Doctor of Nursing Practice Program, DeSales University, and was a DNP student at DeSales University and a CRNP at The Children's Hospital of Philadelphia, Philadelphia, PA, at the time this research was completed.
E. Zachary Ramsey, PharmD, BCPPS, is a PGY2 Residency Director, Department of Pharmacy, The Children's Hospital of Philadelphia, Philadelphia, PA.
Carol G. Mest, PhD, RN, ANP-BC, is Director of the Graduate Nursing Program, DeSales University, Department of Nursing and Health, Center Valley PA.
Theresa DiMaggio, MSN, RN, CRNP, PPCNP-BC, is an Advanced Practice Nurse, The Pain Management Program, Department of Anesthesia and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.
Caption: Figure 1. Comparison of the Outcomes: Pain Scores
Table 1. Comparison of Demographic and Clinical Variables Opioid Alone Rectal Acetaminophen p-Value (n = 21) with Opioid (n = 53) (p < 0.05) Age in weeks 39.2 (1.7) 39.5 (1.3) p < 0.33 Weight in 3.3 (0.6) 3.4 (0.6) p < 0.38 kilograms (kg) Gender Male (n = 46) 17 (81%) 29 (55%) P < 0.06 Female (n = 28) 4 (19%) 24 (45%) Intubated Yes (n = 59) 18 (86%) 41 (77%) P < 0.53 No (n = 15) 3 (14%) 12 (23%) Note: Mean (standard deviation) were reported for continuous variables. Count (Frequency) was reported for categorical variables. Two samples t-test were used to compare continuous variables. Fisher's exact tests were used to compare the categorical variables. Interpretation: There is no statistical difference between the two study groups. Table 2. Comparison of Overall Opioid Exposure Opioid Alone Rectal Acetaminophen p-Value (n = 21) with Opioid (n = 53) p < 0.05 Milligrams 0.28 mg/kg/day 0.11 mg/kg/day p < 0.01 per kg per day (24 (0.16, 0.32) (0.06, 0.21) hours) Notes: Median (Q1, Q3) and p/value for Wilcoxon rank/sum test were reported. Infants who received IV opioid alone used more opioid overall, with a concomitant increased overall opioid exposure, than infants who received standardly prescribed rectal acetaminophen with IV opioid in the first 24 hours post/open heart repair. The median value of opioid usage is 0.28 mg/kg/day in the opioid/alone group. The median usage of the opioid with rectal acetaminophen group is 0.11 mg/kg/day. Interpretation: There is a statistically significant difference in opioid usage between the two study groups (p < 0.01).
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|Author:||Ochsenreither, Jacqueline M.; Ramsey, E. Zachary; Mest, Carol G.; DiMaggio, Theresa|
|Date:||Jul 1, 2017|
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