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

Sponsor

Hospital Infantil Albert Sabin (Other)

Overall Status

Completed

CT.gov ID

NCT03681574

Collaborator

(none)

135

Enrollment

Location

Arms

Actual Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Agitation States as Acute Reaction to Exceptional Stress Anesthesia Vomiting	Drug: Placebo Group Drug: GABA 15mg/kg Group Drug: GABA 30mg/kg Group	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

A pharmacist will prepare the drugs under codes of numbers 1, 2 or 3. The nursing team and anesthesiologists will not know the drug formula used. Drugs will only be revealed after the statistical assessment.

Primary Purpose:

Treatment

Official Title:

Use of Gabapentin as Preanesthetic Medication in Oncologic Children Undergoing in Fast Procedures With Sevofluran

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Placebo Group Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate. Other Names: Lumbar puncture Myelogram
Experimental: 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.	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. Other Names: Lumbar puncture Myelogram
Experimental: 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.	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. Other Names: Lumbar puncture Myelogram

Arm

Intervention/Treatment

Experimental: 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.

Drug: Placebo Group

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

Other Names:

Lumbar puncture

Myelogram

Experimental: 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.

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.

Other Names:

Lumbar puncture

Myelogram

Experimental: 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.

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.

Other Names:

Lumbar puncture

Myelogram

Outcome Measures

Primary Outcome Measures

The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects. [8 hours]
Children, ranging from 1 to 6 years old, will receive drugs (placebo, gabapentin 15mg/kg or 30mg/kg) 1 to 2 hours before the oncologic procedure (myelogram and/ or puncture lumbar). They will be submitted to the same general anesthesia protocol (sevoflurane 8% plus N2O and oxygen) and postoperative analgesia. All patients will be observed for changes in the Modified Yale Preoperative Anxiety Scale (mYPAS) at baseline (right before drug administration), at 1 hour after group administration, at the separation from parents, and at anesthetic induction time. The mYPAS scale is a compilation of 5 subscales: activity (0 to 4 points), vocalizations (0 to 6 points), emotional expressivity (0 to 4 points), state of apparent arousal (0 to 4 points), and use of parent (0 to 4 points). All scores are summed up, divided by 4, and then multiplied by 100. Total scores above 30 points are interpreted as a patient with anxiety, which would represent a worse outcome.

Secondary Outcome Measures

Percentage of sevoflurane consumption in patients over anesthetic induction. [8 hours]
Patients will be submitted to the same general anesthesia protocol, receiving sevoflurane 8% plus N2O and oxygen prior to the procedure. We will measure the percentage of sevoflurane ended-expired.
Level of emergence delirium and agitation in children at post-operative through Paediatric Anaesthesia Emergence Delirium. [1 hour]
After the procedure, all patients will be observed for change in the Paediatric Anaesthesia Emergence Delirium (PAED 0 to 20 points) scale. Score changes will be assessed at baseline (right after the procedure), and at 30 minutes the procedure has finished. Each criterion is assessed through the event frequency, e.g. "eye contact" that "never" occurs corresponds to score 4. The range goes from "never" (4 points) up to "always" (0 points) for positive behavior criteria. Those are "make contact with the caregiver", "actions are purposeful", and "aware of surroundings". Negative behavior criteria range from "never" (0 points) up to "always" (4 points). Those are "restlessness" and "inconsolable". All subscores are summed up into a total score. Total scores above 10 points are interpreted as a patient with emergence delirium, which would indicate a worse outcome.
Frequency of post-operative vomits. [8 hours]
All patients will be evaluated number of vomits occurrence for 8 hours after procedure.
Anesthetic induction time in seconds. [8 hours]
Patients will be submitted to the same general anesthesia protocol, receiving sevoflurane 8% plus N2O and oxygen prior to the procedure. We will record the time, in seconds, when patients lose their consciousness and corneal reflex.
Levels of postoperative pain in children through Children and Infants Postoperative Pain Scale (CHIPPS). [1 hour]
After the procedure, all patients will be observed for changes in the Children and Infants Postoperative Pain Scale (CHIPPS) scores. Score changes will be assessed at baseline (right after the procedure), and at 30 minutes the procedure has finished. The score ranges from 0 (Behavior not present) to 2 (Intense behavior), to be assessed in each of the following indicators: "crying", "facial expression", "posture of the trunk", "posture of legs", and "motor restlessness". All subscores are summed up into a total score. Total scores above 6 points are interpreted as a patient with severe pain, which would indicate a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 6 Years

Sexes Eligible for Study:

All

Accepts 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.