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

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440114
• Other study ID #: PSUEA1
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: September 22, 2011
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 9 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• fentanyl
In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
• NSS
Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat-Yai	Sonkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of emergence agitation		pt was observed since emerging from anesthesia up to 60 minutes	Yes
Secondary	severity of emergence agitation		pt was observed since emerging from anesthesia up to 60 minutes	Yes
Secondary	adverse effect from intravenous fentanyl prior the end of surgery		pt was observed since emerging from anesthesia upto 60 minutes	Yes
Secondary	post operative pain		pt was observed since emerging from anesthesia up to 60 minutes	Yes