Abstract
BackgroundPostoperative 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/designWe 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.DiscussionIn 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 registrationChinese ClinicalTrials.gov ChiCTR1800019411. Registered on 10 November 2018
Highlights
Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications
We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population
The incidence of postoperative pain in children undergoing elective craniotomy will not be lower than that of adults; we provisionally considered 60% as the positive rate in children’s postoperative pain for insurance purposes
Summary
Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. 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. We aimed to compare the effect of dexmedetomidine vs lidocaine on postoperative pain in pediatric patients after craniotomy. High-quality perioperative analgesia is significant to alleviate postoperative pain and can improve the quality of life and rehabilitation efficacy for pediatric patients undergoing neurosurgeries
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