MedTrace Logo

Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology

NCT03681574 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-09-27

No results posted yet for this study

Summary

This study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.

Conditions

  • Pain, Postoperative
  • Agitation States as Acute Reaction to Exceptional Stress
  • Anesthesia
  • Vomiting

Interventions

DRUG

Placebo Group

Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate.

DRUG

GABA 15mg/kg Group

Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 15mg/kg.

DRUG

GABA 30mg/kg Group

Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 30mg/kg.

Sponsors & Collaborators

  • Hospital Infantil Albert Sabin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-07-01
Completion
2018-08-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03681574 on ClinicalTrials.gov