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The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

NCT ID: NCT01440114

Last Updated: 2011-09-26

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

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.

Detailed Description

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Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.

Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fentanyl group

First arm: intervention group. Patient in this group received fentanyl 1 mcg/kg (concentration 10mcg/ml) intravenous route 15 minutes before the end of surgery.

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.

controlled group

patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery

Group Type PLACEBO_COMPARATOR

NSS

Intervention Type DRUG

Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

Interventions

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fentanyl

In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.

Intervention Type DRUG

NSS

Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged between 2-9 years
* IPD patient
* Receiving Chloral hydrate 50mg/kg (BW\<20 kgs)or midazolam 0.1 mg /kg (BW\>20 kgs)Per oral for premedication
* Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.

Exclusion Criteria

* ASA physical status IV-V
* History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Ngamjit Pattaravit

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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PSUEA1

Identifier Type: -

Identifier Source: org_study_id