Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005483
• Other study ID #: HOSPITALIAS
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2016
• Last updated: December 28, 2016
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Hospital Infantil Albert Sabin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthopedic Disorder
• Pain, Postoperative

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Hospital Infantil Albert Sabin	Fortaleza	Ceara

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Infantil Albert Sabin	Fortaleza University

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the pain intensity using the Face Pain Scale	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.	24 hour	Yes
Secondary	Reduce the opioid consumption through 24 hours postoperative observation	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.	24 hour	Yes