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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01440114

Enrollment

144

Registered

2011-09-26

Start date

2010-03-31

Completion date

2011-07-31

Last updated

2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation

Keywords

emergence agitation, pediatric patient, fentanyl, incidence of emergence agitation, severity of emergence agitation, adverse outcome from intervention

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.

Interventions

DRUGfentanyl

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

DRUGNSS

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 9 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026