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Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

NCT ID: NCT02384187

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Nausea and Vomiting (PONV) Adenotonsillectomy

Keywords

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Gabapentin PONV Adenotonsillectomy Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group C

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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 GAB

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

Group Type EXPERIMENTAL

Gabapentin as premedication

Intervention Type 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

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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heba mohamed nassar

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Abdulatif, Professor of Anesthesia

Role: STUDY_CHAIR

Cairo University

Locations

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Kasr Al Ainy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-47-2014

Identifier Type: -

Identifier Source: org_study_id