NCT03681574

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Hospital Infantil Albert Sabin · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6 years. Three groups were compared: the control group received placebo, the other two groups received gabapentin at 15mg/kg or at 30mg/kg. All patients received the same protocols (anesthesia and analgesia). Anesthesia protocol used was induction with sevoflurane 8% plus N2O 50% and oxygen, maintenance with sevoflurane 4%. We provided local analgesia with 5% lidocaine creme before the procedure. If it was required, dipyrone 10mg/kg every 6 hours was given as rescue analgesia. To prevent post-operative vomit, ondasentron 0,1mg/kg was administered when intrathecal chemotherapy. The mYPAS scale was used to evaluate preoperative anxiety at several moments: at basal, at after 1-hour administration, at separation from parents, and at induction. The PAED scale was applied after 30 minutes of procedure to evaluate postoperative agitation. The CHIPPS scale was used to assess postoperative pain. The frequency of vomits was recorded for 8 hours after the procedure finished.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-07-01
• Completion: 2018-08-01
• First posted: 2018-09-24
• Last updated: 2018-09-27

Locations

1 site across 1 country: Brazil