Clinical trial NCT03681574: Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology
Official title: Use of Gabapentin as Preanesthetic Medication in Oncologic Children Undergoing in Fast Procedures With Sevofluran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Agitation States as Acute Reaction to Exceptional Stress
Anesthesia
Vomiting
Keywords: pediatric
gabapentin
agitation
induction
Lead sponsor: Hospital Infantil Albert Sabin
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 135
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects.
timeFrame: 8 hours
Secondary outcomes:
measure: Percentage of sevoflurane consumption in patients over anesthetic induction.
timeFrame: 8 hours
measure: Level of emergence delirium and agitation in children at post-operative through Paediatric Anaesthesia Emergence Delirium.
timeFrame: 1 hour
measure: Frequency of post-operative vomits.
timeFrame: 8 hours
measure: Anesthetic induction time in seconds.
timeFrame: 8 hours
measure: Levels of postoperative pain in children through Children and Infants Postoperative Pain Scale (CHIPPS).
timeFrame: 1 hour
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Infantil Albert Sabin
state: Ceara
Study officials:
References:
citation: 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.
citation: 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.