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

Prince of Songkla University144 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

144

Conditions

Agitation

Interventions

fentanylDRUG

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

NSSDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

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

Time frame: 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

post operative pain

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

Data from ClinicalTrials.gov

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