Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Pain, Postoperative, Orthopedic Disorder

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Gabapentin 10 mg/kg in children submitted unilateral limb surgery | Drug: Gabapentin<br>* Orthopedic Surgery was applied for the treatment of osseous disorders<br>* Other names: Orthopedic Surgery;|
| Placebo Comparator: Placebo<br>Placebo in children submitted unilateral limb surgery | Other: Placebo<br>* Orthopedic Surgery was applied for the treatment of osseous disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GABAPENTIN POSTOPERATIVE PAIN CHILD