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

Prince of Songkla University

Status: Completed

Conditions: Agitation

Treatments: Drug: fentanyl; Drug: NSS

Study type: Interventional

Funder types: Other

Identifiers

NCT01440114

PSUEA1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

fentanyl group

Active Comparator group

Description:

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.

Treatment:

Drug: fentanyl

controlled group

Placebo Comparator group

Description:

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

Treatment:

Drug: NSS