Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial

Abstract Background Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. B...

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Autores principales:	Yuan Zhang, Di Bao, Dongmei Chi, Lu Li, Bin Liu, Di Zhang, Lanxin Qiao, Yi Liang, Yaxin Wang, Xu Jin
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Dexmedetomidine Lidocaine Pediatric Craniotomy Postoperative analgesia Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/fc3c1819111d4315a252be5df29e6898
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spelling	oai:doaj.org-article:fc3c1819111d4315a252be5df29e68982021-11-14T12:31:00ZDexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial10.1186/s13063-021-05774-91745-6215https://doaj.org/article/fc3c1819111d4315a252be5df29e68982021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05774-9https://doaj.org/toc/1745-6215Abstract Background Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy, and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: group D (infusion of dexmedetomidine [intervention group]), group L (infusion of lidocaine [intervention group]), and group C (infusion of normal saline [control group]). Patients will be followed up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery. Discussion In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population. Trial registration Chinese ClinicalTrials.gov ChiCTR1800019411 . Registered on 10 November 2018Yuan ZhangDi BaoDongmei ChiLu LiBin LiuDi ZhangLanxin QiaoYi LiangYaxin WangXu JinBMCarticleDexmedetomidineLidocainePediatricCraniotomyPostoperative analgesiaMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Dexmedetomidine Lidocaine Pediatric Craniotomy Postoperative analgesia Medicine (General) R5-920
spellingShingle	Dexmedetomidine Lidocaine Pediatric Craniotomy Postoperative analgesia Medicine (General) R5-920 Yuan Zhang Di Bao Dongmei Chi Lu Li Bin Liu Di Zhang Lanxin Qiao Yi Liang Yaxin Wang Xu Jin Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
description	Abstract Background Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy, and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: group D (infusion of dexmedetomidine [intervention group]), group L (infusion of lidocaine [intervention group]), and group C (infusion of normal saline [control group]). Patients will be followed up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery. Discussion In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population. Trial registration Chinese ClinicalTrials.gov ChiCTR1800019411 . Registered on 10 November 2018
format	article
author	Yuan Zhang Di Bao Dongmei Chi Lu Li Bin Liu Di Zhang Lanxin Qiao Yi Liang Yaxin Wang Xu Jin
author_facet	Yuan Zhang Di Bao Dongmei Chi Lu Li Bin Liu Di Zhang Lanxin Qiao Yi Liang Yaxin Wang Xu Jin
author_sort	Yuan Zhang
title	Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
title_short	Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
title_full	Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
title_fullStr	Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
title_full_unstemmed	Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
title_sort	dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/fc3c1819111d4315a252be5df29e6898
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Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial

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