NCT03005483

Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital Infantil Albert Sabin · Academic / Other
• Sex: All
• Age: 3 Months – 16 Years
• Healthy volunteers: Accepted

Summary

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.

Detailed description

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .

Conditions

• Pain, Postoperative
• Orthopedic Disorder

Interventions

Type	Name	Description
DRUG	Gabapentin	Orthopedic Surgery was applied for the treatment of osseous disorders
OTHER	Placebo	Orthopedic Surgery was applied for the treatment of osseous disorders

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2016-05-01
• First posted: 2016-12-29
• Last updated: 2016-12-29

Locations

1 site across 1 country: Brazil