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

Hospital Infantil Albert Sabin

Status and phase: Completed; Phase 4

Conditions: Vomiting; Agitation States as Acute Reaction to Exceptional Stress; Pain, Postoperative; Anesthesia

Treatments: Drug: GABA 15mg/kg Group; Drug: Placebo Group; Drug: GABA 30mg/kg Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03681574

HOSPITALIAS2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Placebo Group

Experimental 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.

Treatment:

Drug: Placebo Group

GABA 15mg/kg Group

Experimental 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.

Treatment:

Drug: GABA 15mg/kg Group

GABA 30mg/kg Group

Experimental group

Description:

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.

Treatment:

Drug: GABA 30mg/kg Group