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

Not Applicable

Completed

• Conditions: Agitation
• Interventions: Drug: NSS; Drug: fentanyl

• Registration Number: NCT01440114
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-22
• Last Update Submitted: 2011-09-22
• Study First Posted: 2011-09-26
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled group	NSS	patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
fentanyl group	fentanyl	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.

Primary Outcome Measures

Name	Time	Method
the incidence of emergence agitation	pt was observed since emerging from anesthesia up to 60 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat-Yai, Sonkhla, Thailand