Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

NCT02384187 | Completed Phase 3 DMC

• 1 other identifier: N-47-2014
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%. There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium. Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.

Conditions

Post Operative Nausea and Vomiting (PONV); Adenotonsillectomy

Keywords

Gabapentin; PONV; Adenotonsillectomy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Incidence of PONV

  The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively

  over the first postoperative 6 hours

Secondary Outcomes (6)

• Pediatric Anesthesia Behavior score (PAB)

  within10 minutes before the child falls asleep.

• Incidence and severity of postoperative delirium

  up to 60 minutes after the end of the operation.

• Duration of recovery

  up to 60 minutes after the end of surgery.

• Time to first request of postoperative rescue analgesics.

  over the first postoperative 6 hours

• Postoperative analgesic consumption

  over the first postoperative 6 hours

Study Arms (2)

Group C

PLACEBO COMPARATOR

Patients in this group will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.

Drug: placebo

Group GAB

EXPERIMENTAL

Patients in this group will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia

Drug: Gabapentin as premedication

Interventions

Gabapentin as premedication DRUG

Patients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia

Group GAB

placebo DRUG

Patients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.

Group C

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged (3-12)
• ASA physical status I or II
• Scheduled for adenotonsillectomy surgery in Abu Elrish Al-Mounira Hospital

You may not qualify if:

• Patients who have active infection
• Obstructive sleep apnea
• Cognitive impairment
• Abnormal bleeding profile
• Renal or hepatic dysfunction
• History of allergic reaction to study medications or chronic use of anti-consultants will be excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Gabapentin; Premedication

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Drug Therapy; Therapeutics

Study Officials

• Mohamed Abdulatif, Professor of Anesthesia

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 10, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

EG (1)