Abstract
BackgroundCorrection 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.MethodsThis 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).ResultsPatients (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.ConclusionsPreemptive 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 registrationCHICTR, CTR2100043718, 27/02/2021 http://www.chictr.org.cn/showproj.aspx?proj=122187
Highlights
Correction surgery for cleft palate is recommended between 9 and 18 months of age
Participant Patients suffered from isolated Cleft palate (CL), American Society of anesthesiologists (ASA) physical status I or II, aged 9–24 months, and undergoing palatoplasty were recruited in the study
In this study, fifty-two patients with CL were scheduled and screened and forty patients were enrolled in the research (Fig. 1, Consolidated Standards of Reporting Trials (CONSORT) diagram)
Summary
Correction surgery for cleft palate is recommended between 9 and 18 months of age. Patients suffer from acute pain after palatoplasty. 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. Cleft palate (CL) is one of the most common congenital craniofacial birth defects in human. The prevalence of abnormality is from 3.4 to 22.4 per 10,000 births and has geographic variation, the highest prevalence is among Asians and Latin Americans [1]. Palatoplasty is recommended between 9 and 18 months of age [2], in order to. Surgical correction for velopharyngeal usually induces to significantly acute postoperative pain. The misconception is gradually corrected as the enhancement for understanding of neurobiology pathway for this group
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