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

NCT ID: NCT03681574

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-08-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo Group

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.

Group Type: EXPERIMENTAL

Placebo Group

Intervention Type: DRUG

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

GABA 15mg/kg Group

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.

Group Type: EXPERIMENTAL

GABA 15mg/kg Group

Intervention Type: DRUG

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

GABA 30mg/kg Group

The GABA 30mg/kg group will receive gabapentin syrup orally (30 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.

Group Type: EXPERIMENTAL

GABA 30mg/kg Group

Intervention Type: DRUG

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

Interventions

Placebo Group

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lumbar puncture; Myelogram; Lumbar puncture; Myelogram; Lumbar puncture; Myelogram

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil Albert Sabin

OTHER

Sponsor Role: lead

Responsible Party

washington aspilicueta pinto filho

Principal Investigator, anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Countries

Brazil

References

Rusy 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.

Reference Type: RESULT

PMID: 20418301 (View on PubMed)

Mayell 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.

Reference Type: RESULT

PMID: 25230144 (View on PubMed)

Study Documents

Document Type: Study Protocol

study protocol

View Document

Document Type: Individual Participant Data Set

individual participant data set

View Document

Document Type: Informed Consent Form

consert form

View Document

Document Type: Statistical Analysis Plan

statistical plan

View Document

Other Identifiers

HOSPITALIAS2

Identifier Type: -

Identifier Source: org_study_id