Clinical trial · Interventional
Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology
Use of Gabapentin as Preanesthetic Medication in Oncologic Children Undergoing in Fast Procedures With Sevofluran
NCT03681574CI-TRIAL-00035050completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Agitation States as Acute Reaction to Exceptional Stress | — | UNRESOLVED | — |
| Anesthesia | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GABA 15mg/kg Group | Drug | — | UNRESOLVED |
| GABA 30mg/kg Group | Drug | — | UNRESOLVED |
| Placebo Group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Placebo Group
- description
- The placebo group will receive placebo concentrate orally (0.3 mL/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture.
- interventionNames
- Drug: Placebo Group
- type
- EXPERIMENTAL
- label
- GABA 15mg/kg Group
- description
- The GABA 15mg/kg group will receive gabapentin syrup orally (15 mg/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture.
- interventionNames
- Drug: GABA 15mg/kg Group
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 6 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTRusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2. PMID 20418301
- RESULTMayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17. PMID 25230144