Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
| Registry | NCT03005483 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Hospital Infantil Albert Sabin (Other); collaborators: Fortaleza University |
| Conditions | Pain, Postoperative, Orthopedic Disorder |
| Interventions | Gabapentin, Placebo (Drug, other) |
| Dates | start 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 in Brazil |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Postoperative All trials for Orthopedic Disorder All trials of Gabapentin All trials of Placebo
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.
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 .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin | Gabapentin 10 mg/kg in children submitted unilateral limb surgery |
| Placebo | Placebo comparator | Other: Placebo | Placebo in children submitted unilateral limb surgery |
Sex: All, ages: 3 Months to 16 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Infantil Albert Sabin | Fortaleza, Ceará | Brazil |