CompletedPhase 4

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

Brazil135 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range1 Year – 6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cancer or under investigation for cancer. * Children between 1 and 6 years. * Previously submitted to oncologic procedures, e.g. myelogram or puncture lumbar. Exclusion Criteria: * Cardiac disease. * Pulmonary disease. * Renal disease. * Neurological disease. * Any allergies. * Refusal of parents, caregivers or patients to participate in the study.

What they're measuring

The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects.

Timeframe: 8 hours

Trial details

NCT IDNCT03681574

SponsorHospital Infantil Albert Sabin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-01

View on ClinicalTrials.gov More Pain, Postoperative trials