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

Abstract

Background 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. Methods This 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. Results The 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. Conclusions Hydromorphone 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 registration Chinese Clinical Trial Register ChiCTR-INR-17013935). Clinical trial registry URL: Date of registration: December 14, 2017.

Effectiveness of Sufentanil‐Based Patient‐Controlled Analgesia Regimen in Children and Incidence of Adverse Events Following Major Congenital Structure Repairs

“…Tramadol was previously considered a safe and effective postoperative analgesia, and was widely used for pediatric postoperative pain treatment. Hullett et al 8 found that tramadol was a suitable drug for children undergoing adenotonsillectomy for obstructive sleep apnea. Ozalevli et al 9 also found that intravenous patient‐controlled tramadol is an alternative to patient‐controlled morphine for postoperative pain relief in children after tonsillectomy.…”

Hydromorphone Prescription for Pain in Children—What Place in Clinical Practice?

“…In children, the efficacy of hydromorphone to treat perioperative pain has been demonstrated in a small number of studies when administered IV, either in bolus, continuous or PCA ( 14 , 43 , 54 – 60 ). The efficacy of epidural administration has also been established ( 61 – 67 ) and a recent study showed the efficacy of intranasal administration ( 68 ).…”

“…These studies, whatever the route of administration, primarily included children and adolescents. Only two of them included infants ( 54 , 59 ). These studies showed good tolerance of hydromorphone in infants, children and adolescents.…”

Effectiveness of perioperative low-dose esketamine infusion for postoperative pain management in pediatric urological surgery: a prospective clinical trial

“…If the FLACC or NRS score remained ≥ 4 after three or more PCA compressions, a remedy of 0.2 mg/kg ketorolac tromethamine was administered to enhance analgesia. The Ramsey Sedation Scale is one of the commonly used methods to assess the level of perioperative sedation in children [ 13 – 15 ]. Therefore, Ramsey Sedation Scale was used in this study to assess the level of postoperative sedation.…”