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Published in: BMC Pediatrics 1/2021

Open Access 01-12-2021 | Opioids | Research

Preemptive analgesic effectiveness of single dose intravenous ibuprofen in infants undergoing cleft palate repair: a randomized controlled trial

Authors: Zhe Zhe Peng, Yan Ting Wang, Ma Zhong Zhang, Ji Jian Zheng, Jie Hu, Wan Ru Zhou, Ying Sun

Published in: BMC Pediatrics | Issue 1/2021

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Abstract

Background

Correction surgery for cleft palate is recommended between 9 and 18 months of age. Patients suffer from acute pain after palatoplasty. Clinicians are hesitant to use opioids for analgesia concerning the potential high risk of respiratory adverse events. Intravenous ibuprofen perhaps be a suitable adjuvant to pain relief. We try to assess whether preoperative administration of intravenous ibuprofen can decrease opioid requirements following cleft palate repair in infants.

Methods

This single center prospective randomized clinical trial was performed from February to April 2021 at Department of Anesthesiology in Shanghai Children’s Medical Center. Forty patients ASA I-II, aged 9–24 months with isolated cleft palate and undergoing palatoplasty were randomized in a 1:1 ratio to receive either a single dose of 10 mg/kg ibuprofen intravenously or normal saline at induction. Children and infants postoperative pain scale (CHIPPS) was used for pain assessment. Those patients CHIPPS pain score equal or higher than 4 received analgesic rescue with titrating intravenous fentanyl 0.5 μg/kg and repeated in 10 min if required. The primary outcome was the amount of postoperative fentanyl used for rescue analgesia in postanesthesia care unit (PACU).

Results

Patients (n = 20 in each group) in IV-Ibuprofen group required less postoperative fentanyl than those in placebo group (p<0.001). There was no significant difference between two groups in first rescue analgesia time (p = 0.079) and surgical blood loss (p = 0.194). No incidence of obvious adverse events had been found within the first 24 h after surgery in both groups.

Conclusions

Preemptive intravenous administration ibuprofen 10 mg/kg at induction had a significant opioid sparing effect in early postoperative period without obvious adverse effects in infants undergoing palatoplasty.

Trial registration

Literature
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go back to reference Moss JR, Watcha MF, Bendel LP, et al. A multicenter, randomized, double-blind placebo-controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy. Paediatr Anaesth. 2014;24(5):483–9. https://doi.org/10.1111/pan.12381.CrossRefPubMed Moss JR, Watcha MF, Bendel LP, et al. A multicenter, randomized, double-blind placebo-controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy. Paediatr Anaesth. 2014;24(5):483–9. https://​doi.​org/​10.​1111/​pan.​12381.CrossRefPubMed
Metadata
Title
Preemptive analgesic effectiveness of single dose intravenous ibuprofen in infants undergoing cleft palate repair: a randomized controlled trial
Authors
Zhe Zhe Peng
Yan Ting Wang
Ma Zhong Zhang
Ji Jian Zheng
Jie Hu
Wan Ru Zhou
Ying Sun
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2021
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-021-02907-6

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