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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
Comparison of continuous infusion of fentanyl to bolus dosing in neonates after surgery.
Journal of Pediatric Surgery 1996 December
OBJECTIVE: Concern about respiratory depression may lead to underuse of postoperative narcotic analgesia in neonates. The authors compared continuous infusion of fentanyl with bolus dosing in infants after surgery to determine whether continuous infusion is associated with less respiratory depression.
STUDY DESIGN: In the first phase of the study, 16 patients were randomly assigned to receive fentanyl by continuous infusion (C) or bolus dosing every 2 hours (B) in a double-blinded trial. Respiratory events were recorded. An observational pain score and saliva for cortisol concentration were obtained 2, 8, and 24 hours after beginning treatment to compare efficacy of pain control. In the second phase, 20 additional patients received fentanyl by continuous infusion in an unblinded fashion, with the same data collection, to more accurately determine the incidence of respiratory events.
RESULTS: In phase 1, apnea occurred in eight of nine B patients (89%) compared with one of seven C patients (14%; P < .009), prompting termination of the randomized trial. The incidence of apnea or significant respiratory depression in the next 20 patients (phase 2) who received fentanyl by continuous infusion was 25% (5 of 20; P < .01 v B). Episodes of apnea in B patients required significantly more intervention than episodes in C patients (P < .01). However, in phase 2, more patients remained intubated and ventilated than in phase 1. Pain scores and salivary cortisol concentrations decreased over the 24-hour study period and were similar in B and C patients during both phases of the study.
CONCLUSION: Continuous infusion of fentanyl at the doses studied is associated with pain control similar to that with bolus dosing at regular intervals. Although episodes of respiratory depression were less severe and less frequent for C patients, there may be an increased need for ventilator support with continuous infusion of fentanyl to achieve acceptable pain control. Providing adequate pain control to neonates in the immediate postoperative period remains a challenge.
STUDY DESIGN: In the first phase of the study, 16 patients were randomly assigned to receive fentanyl by continuous infusion (C) or bolus dosing every 2 hours (B) in a double-blinded trial. Respiratory events were recorded. An observational pain score and saliva for cortisol concentration were obtained 2, 8, and 24 hours after beginning treatment to compare efficacy of pain control. In the second phase, 20 additional patients received fentanyl by continuous infusion in an unblinded fashion, with the same data collection, to more accurately determine the incidence of respiratory events.
RESULTS: In phase 1, apnea occurred in eight of nine B patients (89%) compared with one of seven C patients (14%; P < .009), prompting termination of the randomized trial. The incidence of apnea or significant respiratory depression in the next 20 patients (phase 2) who received fentanyl by continuous infusion was 25% (5 of 20; P < .01 v B). Episodes of apnea in B patients required significantly more intervention than episodes in C patients (P < .01). However, in phase 2, more patients remained intubated and ventilated than in phase 1. Pain scores and salivary cortisol concentrations decreased over the 24-hour study period and were similar in B and C patients during both phases of the study.
CONCLUSION: Continuous infusion of fentanyl at the doses studied is associated with pain control similar to that with bolus dosing at regular intervals. Although episodes of respiratory depression were less severe and less frequent for C patients, there may be an increased need for ventilator support with continuous infusion of fentanyl to achieve acceptable pain control. Providing adequate pain control to neonates in the immediate postoperative period remains a challenge.
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