Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

NCT ID: NCT03347916

Last Updated: 2017-11-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-11-30

Brief Summary

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to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery

Detailed Description

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Conditions

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Emergence Agitation After Desflurane Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

patients received strawberry juice 5 ml volume, one hour before induction.

Group Type PLACEBO_COMPARATOR

Strawberry juice as (placebo)

Intervention Type DRUG

Patients received strawberry juice 5 ml volume, one hour before induction.

Gabapentin group

patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.

Group Type ACTIVE_COMPARATOR

Gabapentin Oral Solution [Neurontin]

Intervention Type DRUG

Patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.

Interventions

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Strawberry juice as (placebo)

Patients received strawberry juice 5 ml volume, one hour before induction.

Intervention Type DRUG

Gabapentin Oral Solution [Neurontin]

Patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.

Intervention Type DRUG

Other Intervention Names

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Strawberry juice Neurontin

Eligibility Criteria

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Inclusion Criteria

* pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle)

Exclusion Criteria

* failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuwait Specialized Eye Center

OTHER

Sponsor Role lead

Responsible Party

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Ahmed A. Badawy

Anesthesia Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kuwait Specialized Eye Center

Kuwait City, , Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Ahmed A. BAdawy, MD

Role: CONTACT

Phone: +96597700293

Email: [email protected]

Nicolas Abou Chaar, MsSc

Role: CONTACT

Phone: +96597714558

Email: [email protected]

Facility Contacts

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Nicolas Abou chaar, MSSc

Role: primary

References

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Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5.

Reference Type DERIVED
PMID: 29925328 (View on PubMed)

Other Identifiers

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kuwaiteyecenter01

Identifier Type: -

Identifier Source: org_study_id