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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: fentanyl
* Drug: NSS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl group<br>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<br>* In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.<br>|
| Placebo Comparator: controlled group<br>patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery | Drug: NSS<br>* Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of emergence agitation |  | pt was observed since emerging from anesthesia up to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence agitation, pediatric patient, fentanyl, incidence of emergence agitation, severity of emergence agitation, adverse outcome from intervention