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Clinical Trials/NCT01440114
NCT01440114
Completed
Not Applicable

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

Prince of Songkla University1 site in 1 country144 target enrollmentMarch 2010
ConditionsAgitation
InterventionsfentanylNSS

Overview

Phase
Not Applicable
Intervention
fentanyl
Conditions
Agitation
Sponsor
Prince of Songkla University
Enrollment
144
Locations
1
Primary Endpoint
the incidence of emergence agitation
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ngamjit Pattaravit

Doctor

Prince of Songkla University

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: fentanyl

controlled group

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

Intervention: NSS

Outcomes

Primary Outcomes

the incidence of emergence agitation

Time Frame: pt was observed since emerging from anesthesia up to 60 minutes

Secondary Outcomes

  • severity of emergence agitation(pt was observed since emerging from anesthesia up to 60 minutes)
  • adverse effect from intravenous fentanyl prior the end of surgery(pt was observed since emerging from anesthesia upto 60 minutes)
  • post operative pain(pt was observed since emerging from anesthesia up to 60 minutes)

Study Sites (1)

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