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

NCT01440114 | Completed

• 1 other identifier: PSUEA1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the incidence of emergence agitation

  pt was observed since emerging from anesthesia up to 60 minutes

Secondary Outcomes (3)

• 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

Study Arms (2)

fentanyl group

ACTIVE COMPARATOR

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.

Drug: fentanyl

controlled group

PLACEBO COMPARATOR

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

Drug: NSS

Interventions

fentanyl DRUG

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

fentanyl group

NSS DRUG

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

controlled group

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• ASA physical status IV-V
• History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Psychomotor Agitation; Emergence Delirium

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Delirium; Confusion; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

TH (1)