Effectiveness of analgesia with hydromorphone hydrochloride for postoperative pain following surgical repair of structural congenital malformations in children: a randomized controlled trial

Yongying Pan,Xingrong Song,Huaizhen Wang,Xi Chen,Liumei Chen,Liangming Peng,Dongxu Lie,Huiying Liang,Yimin Wang,Di Liu,Zeyan Wu,Baisong Zhao

doi:10.1186/s12871-021-01412-8

Abstract

BackgroundEffective postoperative analgesia is needed to prevent the negative effects of postoperative pain on patient outcomes. To compare the effectiveness of hydromorphone hydrochloride and sufentanil, combined with flurbiprofen axetil, for postoperative analgesia in pediatric patients.MethodsThis prospective randomized controlled trial included 222 pediatric patients scheduled for repair of a structural congenital malformation under general anesthesia. Patients were randomized into 3 groups: hydromorphone hydrochloride 0.1 mg/kg (H1), hydromorphone hydrochloride 0.2 mg/kg; (H2) or sufentanil 1.5 µg/kg (S). Analgesics were diluted in 0.9% saline to 100 ml and infused continuously at a basic flow rate of 2 mL per h. The primary outcome measure was the Face, Legs, Activity, Cry, and Consolability (FLACC) pain score. Secondary outcomes included heart rate (HR), respiration rate (RR), SpO2, Ramsay sedation scores, scores on the Paediatric Anaesthesia Emergence Delirium (PAED) scale, adverse reactions, parent satisfaction with analgesia.ResultsThe FLACC score was significantly lower in H1 and H2 groups compared to S. The Ramsay sedation score was significantly higher in H1 and H2 groups compared to S. Recovery time was shorter in H1 group compared to patients H2 group or S group. There were no significant differences in the PAED scale, HR, RR, SpO2, adverse reactions, satisfaction of parents with analgesia, or length and cost of hospital stay.ConclusionsHydromorphone hydrochloride is a more effective analgesic than sufentanil for postoperative pain in pediatric patients following surgical repair of a structural congenital malformation, however, hydromorphone hydrochloride and sufentanil had similar safety profiles in this patient population.Trial registrationChinese Clinical Trial Register ChiCTR-INR-17013935). Clinical trial registry URL: Date of registration: December 14, 2017.

Highlights

Effective postoperative analgesia is needed to prevent the negative effects of postoperative pain on patient outcomes
There were no significant differences in duration of analgesia or surgery, amount of propofol, sevoflurane, sufentanil, cisatracurium, tropisetron, penehyclidine hydrochloride or flurbiprofen axetil administered in the intraoperative period, or length and cost of hospital stay between the three groups (Table 1)
There were no significant differences in the Paediatric Anaesthesia Emergence Delirium (PAED) scale, the FLACC pain score, or the Ramsay sedation score after extubation (Table 2)

Summary

Introduction

Effective postoperative analgesia is needed to prevent the negative effects of postoperative pain on patient outcomes. To compare the effectiveness of hydromorphone hydrochloride and sufentanil, combined with flurbiprofen axetil, for postoperative analgesia in pediatric patients. Surgical repair is the primary treatment for structural congenital malformations. Surgical repair of structural congenital malformations can result in severe postoperative pain [2], which can cause sleep disturbances and changes in behavior, and negatively impact a child’s physical and mental health [3]. Several studies showed that regional anesthesia, maxillary nerve block, or pudendal or caudal block provided analgesia for repair of structural congenital malformations in children [4,5,6]. The comparative effectiveness of analgesics cannot be evaluated, as the studies used different concentrations of local anesthetic [2,3,4,5,6,7]

Methods

Results

Discussion

Conclusion