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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Vomiting; Anesthesia; Agitation States as Acute Reaction to Exceptional Stress
• Intervention / Treatment: Drug: Placebo Group; Drug: GABA 15mg/kg Group; Drug: GABA 30mg/kg Group

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Ceara
    • Fortaleza, Ceara, Brazil, 60410794
      • Hospital Infantil Albert Sabin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects.	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.	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of sevoflurane consumption in patients over anesthetic induction.	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.	8 hours
Level of emergence delirium and agitation in children at post-operative through Paediatric Anaesthesia Emergence Delirium.	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.	1 hour
Frequency of post-operative vomits.	All patients will be evaluated number of vomits occurrence for 8 hours after procedure.	8 hours
Anesthetic induction time in seconds.	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.	8 hours
Levels of postoperative pain in children through Children and Infants Postoperative Pain Scale (CHIPPS).	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.	1 hour

Collaborators and Investigators

• Sponsor: Hospital Infantil Albert Sabin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pediatric; agitation; gabapentin; induction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Signs and Symptoms, Digestive; Dyskinesias; Psychomotor Disorders; Pain, Postoperative; Vomiting; Psychomotor Agitation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; GABA Agents; gamma-Aminobutyric Acid
• Other Study ID Numbers: HOSPITALIAS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: study protocol
   Information comments: study protocol
2. Individual Participant Data Set
   Information identifier: data set
   Information comments: individual participant data set
3. Informed Consent Form
   Information identifier: informed consent form
   Information comments: consert form
4. Statistical Analysis Plan
   Information identifier: statistical plan
   Information comments: statistical plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No