Randomized Clinical Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2022; 10(21): 7376-7385
Published online Jul 26, 2022. doi: 10.12998/wjcc.v10.i21.7376
Dexmededomidine in pediatric unilateral internal inguinal ring ligation
Guang Liu, Ling Zhang, Hui-Se Wang, Yi Lin, Hong-Quan Jin, Xiao-Dan Wang, Wei-Na Qiao, Ya-Tao Zhang, Jiao-Qian Sun, Zhi-Na Liu
Guang Liu, Ling Zhang, Hui-Se Wang, Yi Lin, Hong-Quan Jin, Xiao-Dan Wang, Wei-Na Qiao, Ya-Tao Zhang, Jiao-Qian Sun, Zhi-Na Liu, Department of Anesthesiology, Baoding Children's Hospital, Baoding 071000, Hebei Province, China
Author contributions: Zhang L and Liu ZN have full access to all the data in the study and are responsible for the integrity of the data and the accuracy of the data analysis; Liu G and Liu ZN contributed to conception and design of the study; Wang HS and Lin Y contributed to project supervision; Jin HQ, Wang XD, and Qiao WN drafted the manuscript; all authors contributed to acquisition, analysis, and interpretation of the data, read and critically revised the manuscript, and approved the final manuscript.
Institutional review board statement: This study was conducted in agreement with the GCP standards and Declaration of Helsinki, and approved by the Ethics Committee of the Baoding Children’s Hospital (approval No. 201829).
Clinical trial registration statement: The registration No. ChiCTR2000034105.
Informed consent statement: The parents of all children provided informed consent.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zhi-Na Liu, BA, Department of Anesthesiology, Baoding Children's Hospital, No. 3399 Hengxiang North Street, Baoding 071000, Hebei Province, China. wenwen9604@163.com
Received: November 18, 2021
Peer-review started: November 18, 2021
First decision: December 27, 2021
Revised: February 21, 2022
Accepted: June 4, 2022
Article in press: June 4, 2022
Published online: July 26, 2022
Processing time: 235 Days and 5.1 Hours
Abstract
BACKGROUND

Safe and effective analgesia strategy remains one of the priorities for pediatric inguinal hernia treatment.

AIM

To explore safety and efficacy of dexmededomidine monotherapy for postoperative analgesia in children who received laparoscopic unilateral internal inguinal ring ligation.

METHODS

This randomized single-center controlled trial included 390 children (aged 1-3 years, ASA grade I-II), randomly divided into a dexmededomidine group (D group), a dexmededomidine + sufentanil group (DS group), and a sufentanil group (S group). The primary endpoint was percentage of children with the Face, Legs, Activity, Cry, and Consolability (FLACC) score ≤ 3 points 2 h after surgery.

RESULTS

The comparisons of the FLACC scores at 2, 4, 6, 8, 12, and 24 h were not significantly different among the three groups (P > 0.05). The sedative effects in the D group were significantly better than those in the S group (P > 0.05), but not significantly different from those in the DS group. The incidence of nausea and vomiting was significantly lower in the D group than in the S group and DS group (P > 0.05).

CONCLUSION

Analgesic effects of dexmededomidine monotherapy are comparable to those of sufentanil alone or in combination with dexmededomidine for children who underwent laparoscopic unilateral internal inguinal ring ligation, with better sedative effects and a lower incidence of adverse events.

Keywords: Child; Dexmededomidine; Inguinal hernia; Pain management; Laparoscopy; Analgesics

Core Tip: This randomized controlled trial aimed to evaluate the safety and efficacy of dexmededomidine monotherapy in children who underwent laparoscopic unilateral internal inguinal ring ligation. A total of 390 children were included and randomly divided into a dexmededomidine group, a dexmededomidine + sufentanil group, and a sufentanil group. Our study suggested that the analgesic effects of dexmededomidine monotherapy were comparable to those of sufentanil alone or in combination with dexmededomidine for children who underwent laparoscopic unilateral internal inguinal ring ligation, and reported better sedative effects along with a significantly lower incidence of adverse events.