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

- Effectiveness of analgesia.
- with hydromorphone hydrochloride.
- for postoperative pain following surgical.
- repair of structural congenital malformations in children: a randomized controlled trial.
- 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: hydromor- phone hydrochloride 0.1 mg/kg (H1), hydromorphone hydrochloride 0.2 mg/kg.
- (H2) or sufentanil 1.5 µg/kg (S)..
- The Ramsay sedation score was significantly higher in H1 and H2 groups compared to S.
- 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..
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- Early surgical repair is the primary treatment for structural congenital malformations.
- Surgical repair of structural congenital malformations can result in severe postop- erative pain [2], which can cause sleep disturbances and changes in behavior, and negatively impact a child’s phys- ical 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 [4–6].
- Currently, intravenous analgesia is preferred for post- operative pain control following repair of structural con- genital malformations.
- Studies investigating the effectiveness of sufentanil or hydromorphone for analgesia in pediatric patients undergoing surgery for repair of structural congenital malformations are scarce.
- This randomized controlled trial compared the effectiveness of hydromorphone hydrochloride and sufentanil, combined with flurbi- profen axetil, for postoperative analgesia in pediat- ric patients undergoing surgical repair of structural.
- congenital malformations [11, 12].
- Two doses of hydro- morphone hydrochloride were used to determine which dose of hydromorphone hydrochloride was most effective for postoperative pain but associated with the fewest adverse events.
- Flurbiprofen axetil is an inject- able nonsteroidal anti-inflammatory drug (NSAID) that provides an excellent analgesic effect in multimodal analgesia after various pediatric procedures [13, 14]..
- and written informed consent was obtained from par- ents or legal guardians of the children included in the trial..
- Children undergoing surgical repair of a structural con- genital malformation under general anesthesia at Guang- zhou Women and Children’s Medical Center between February 2018 and June 2018 were eligible for this trial..
- 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 hydro- chloride and sufentanil had similar safety profiles in this patient population..
- Keywords: Analgesic effectiveness, Hydromorphone hydrochloride, Structural congenital malformation, Children, Randomized controlled trial.
- Patients were randomized 1:1:1 using a computer-gener- ated randomization table into 3 groups: hydromorphone hydrochloride 0.1 mg/kg (H1, n = 74), hydromorphone hydrochloride 0.2 mg/kg (H2, n = 74), or sufentanil 1.5 µg/kg (S, n = 74).
- All patients received flurbiprofen axetil 5 mg/kg.
- The researchers and other medical staff in the operation room were blinded to the group allocation until after the study had been completed.
- The child, their parents or legal guardians and family, and the nurses on the ward were not blinded to the group allocation..
- Preoperatively, propofol 1.0 mg/kg was injected intrave- nously for sedation.
- After peripheral intravenous access was established, and prior to incision, patients received an infusion of cisatracurium (0.2 mg/kg), sufentanil 0.3 ug/kg, propofol (2.5–3.0 mg/.
- kg), and flurbiprofen axetil (1 mg/kg).
- Tropisetron 0.1 mg/kg was administered by intravenous injection.
- Patients were transferred to the post-anesthesia care unit (PACU).
- Supplemen- tal oxygen was provided, and patients were monitored for 30 min in the PACU..
- Scores on the Paediatric Anaesthesia Emergence Delirium (PAED) scale (5 psychometric items scored on a scale from the FLACC pain score, and the Ramsay sedation score were recorded after extubation..
- 3, unsatisfied), and the length and cost of the hospital stay were also recorded..
- A mixed effect model was used to evaluate the FLACC pain score, Ram- say sedation score, HR, RR, and SpO2.
- therefore, data from 222 patients were included in the analyses (n = 74 in each group) (Supplementary Fig.
- There were no significant differences in duration of analgesia or surgery, amount of propofol, sevoflurane, sufentanil, cisatracurium, tropise- tron, penehyclidine hydrochloride or flurbiprofen axetil administered in the intraoperative period, or length and cost of hospital stay between the three groups (Table 1)..
- Results from the mixed effect model showing the dif- ferences in the FLACC pain score, Ramsay sedation.
- The FLACC pain score was significantly lower in patients who received hydromorphone hydrochloride 0.1 mg/kg (P <.
- 0.01) or hydromorphone hydrochloride 0.2 mg/kg (P = 0.01) compared to patients who received sufentanil 1.5 µg/kg.
- There was no significant difference in FLACC pain score in patients who received hydro- morphone hydrochloride 0.1 mg/kg or hydromorphone hydrochloride 0.2 mg/kg (Fig.
- The Ramsay sedation score was significantly higher in patients who received hydromorphone hydrochloride 0.2 mg/kg compared to patients who received sufentanil 1.5 µg/kg (P <.
- There was no significant difference in the Ramsay sedation score in patients who received hydromorphone hydrochloride 0.2 mg/kg or sufentanil 1.5 µg/kg compared to patients who received hydromor- phone hydrochloride 0.1 mg/kg (Fig.
- Recovery time was shorter in patients who received hydromorphone hydrochloride 0.1 mg/kg compared to patients who received hydromorphone hydrochloride 0.2 mg/kg vs.
- min) or sufenta- nil 1.5 µg/kg vs.
- There were no significant differences in the PAED scale, the FLACC pain score, or the Ramsay sedation score.
- To the author’s knowledge, this is the first randomized, single-blind controlled trial comparing hydromorphone hydrochloride with sufentanil, in combination with flur- biprofen axetil, for postoperative analgesia following sur- gical repair of structural congenital malformations in a pediatric patient population.
- Most studies have reported on the analgesic effects of hydromorphone and sufentanil and the incidence of adverse reactions in adults.
- Yanqing Yang et al.
- Patients were randomized 1:1:1 into 3 groups: hydromorphone hydrochloride 0.1 mg/kg (H1), hydromorphone hydrochloride 0.2 mg/kg (H2), or sufentanil 1.5 µg/kg (S).
- Surgery 0.980 (Chi Square Test).
- Flurbiprofen axetil (mg).
- In the present study, pediatric patients received mul- timodal analgesia consisting of hydromorphone hydro- chloride or sufentanil in combination with flurbiprofen axetil to improve patient safety and quality of surgical care [19].
- Flurbiprofen axetil is an NSAID with high affin- ity to the site of surgical incision and inflammatory tis- sues, which exerts its effects through peripheral and central mechanisms and has synergistic analgesic effects with opiods [19, 20].
- Evidence suggests that parental hydromorphone hydro- chloride is 5–6.7 times as potent as morphine sulfate [22], parenteral sufentanil is 1000 times as potent as mor- phine sulfate, and sufentanil is 150–200 times as potent as hydromorphone hydrochloride.
- Therefore, in the present study, we estimate that sufentanil 1.5 µg/kg was 150 times as potent as hydromorphone hydrochloride Fig.
- 2 Postoperative Ramsay sedation scores.
- 0.1 mg/kg and 75 times as potent as hydrochloride 0.2 mg/kg.
- Of note, hydromorphone administered by target-controlled infusion and patient- controlled analgesia (PCA) to postoperative adult cardiac surgery patients improved mood, which is closely related to pain relief, likely due to the anti-anxiety and the anti- depression effects induced by activation of δ-opioid receptors.
- Sufentanil’s short duration of analgesia may be explained by its low affinity for the δ-opioid receptor and rapid redistribution [24]..
- In the present study, the Ramsay sedation score was significantly higher in patients who received hydromor- phone hydrochloride 0.2 mg/kg compared to patients who received sufentanil 1.5 µg/kg.
- This was likely medi- ated by the action of hydrophone on the δ-opioid recep- tor in the central nervous system, which produces a sedative effect.
- In our patient population, there were no signifi- cant differences in the incidence of PONV or pruritus or in postoperative HR, RR or SpO 2 in patients who received hydromorphone hydrochloride 0.1 mg/kg, hydromor- phone hydrochloride 0.2 mg/kg, or sufentanil 1.5 µg/.
- PONV is influenced by various factors, including the anesthetic, surgical approach, and patient demographic Table 2 FLACC, Ramsay and PAED scores in the post anesthesia.
- In the present study, were no significant differences in age, gender, body weight, type of surgery, operative or anesthesia time, or intraoperative opioid or other drug use in patients who received hydromorphone hydrochloride 0.1 mg/.
- kg, hydromorphone hydrochloride 0.2 mg/kg, or sufen- tanil 1.5 µg/kg.
- These data confirm the safety of hydro- morphone hydrochloride or sufentanil for postoperative analgesia in pediatric patients undergoing surgical repair of structural congenital malformations.
- Consistent with this, in a previous study, pediatric patients who received a PCA were more likely to switch from morphine-to- hydromorphone than vice-versa as hydromorphone pro- vided improved pain control and fewer side effects [9]..
- No patients required rescue analgesia in this study..
- Last, the study was not powered to look at the side- effects of the pain control methods..
- In conclusion, hydromorphone hydrochloride is a more effective analgesic than sufentanil for postopera- tive pain in pediatric patients following surgical repair of a structural congenital malformation under general anesthesia.
- however, hydromorphone hydrochloride.
- We recommend hydromorphone hydrochloride 0.1 mg/kg for postoperative pain in pedi- atric patients following surgical repair of a structural congenital malformation, as this dose was associated with better recovery and more consistent sedation than hydromorphone hydrochloride 0.2 mg/kg..
- The authors declare that the funding body was not involved in study design, data collec- tion, analysis, interpretation and writing of the study..
- Written informed consent was obtained from parents or legal guardians of the children included in the trial..
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