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

September 22, 2011 updated by: Ngamjit Pattaravit, Prince of Songkla University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Sonkhla
      • Hat-Yai, Sonkhla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: fentanyl
In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
PLACEBO_COMPARATOR: controlled group
patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
Drug: NSS
Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of emergence agitation
Time Frame: pt was observed since emerging from anesthesia up to 60 minutes
pt was observed since emerging from anesthesia up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of emergence agitation
Time Frame: pt was observed since emerging from anesthesia up to 60 minutes
pt was observed since emerging from anesthesia up to 60 minutes
adverse effect from intravenous fentanyl prior the end of surgery
Time Frame: pt was observed since emerging from anesthesia upto 60 minutes
pt was observed since emerging from anesthesia upto 60 minutes
post operative pain
Time Frame: pt was observed since emerging from anesthesia up to 60 minutes
pt was observed since emerging from anesthesia up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (ESTIMATE)

September 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSUEA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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