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Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

NCT02384187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-12-23

No results posted yet for this study

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

Interventions

DRUG

Gabapentin as premedication

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

DRUG

placebo

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Abdulatif, Professor of Anesthesia · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02384187 on ClinicalTrials.gov