Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Overview

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.

Full Title of Study: “Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2015

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 .

Interventions

  • Drug: Gabapentin
    • Orthopedic Surgery was applied for the treatment of osseous disorders
  • Other: Placebo
    • Orthopedic Surgery was applied for the treatment of osseous disorders

Arms, Groups and Cohorts

  • Experimental: Gabapentin
    • Gabapentin 10 mg/kg in children submitted unilateral limb surgery
  • Placebo Comparator: Placebo
    • Placebo in children submitted unilateral limb surgery

Clinical Trial Outcome Measures

Primary Measures

  • Reduce the pain intensity using the Face Pain Scale
    • Time Frame: 24 hour
    • Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.

Secondary Measures

  • Reduce the opioid consumption through 24 hours postoperative observation
    • Time Frame: 24 hour
    • 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 administered morphine 50mcg / kg (maximum dose of 2mg) up to 2 / 2h when Face´s Scales reached 5 points.

Participating in This Clinical Trial

Inclusion Criteria

Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery Exclusion Criteria:

Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Infantil Albert Sabin
  • Collaborator
    • Fortaleza University
  • Provider of Information About this Clinical Study
    • Principal Investigator: washington aspilicueta pinto filho, Medical Anesthesiologist – Hospital Infantil Albert Sabin
  • Overall Official(s)
    • Josenília Gomes, PhD, Study Chair, Fortaleza University

References

Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.

Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.

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