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NCT Number: NCT03005483

Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

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.

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Key information

Conditions

Pain, Postoperative Musculoskeletal Diseases Neurologic Manifestations Orthopedic Disorder Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Infantil Albert Sabin

Fortaleza, Ceará, 60410794, Brazil

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Orthopedic Surgery was applied for the treatment of osseous disorders

Other names: Orthopedic Surgery

Placebo

Other

Orthopedic Surgery was applied for the treatment of osseous disorders

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Infantil Albert Sabin

Other

Collaborators

  • Fortaleza University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 29, 2016
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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