Back to resultsThe Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
Primary Purpose
Agitation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
fentanyl
NSS
Sponsored by
About this trial
This is an interventional prevention trial for Agitation focused on measuring emergence agitation, pediatric patient, fentanyl, incidence of emergence agitation, severity of emergence agitation, adverse outcome from intervention
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
fentanyl group
controlled group
Arm 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.
patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
Outcomes
Primary Outcome Measures
the incidence of emergence agitation
Secondary Outcome Measures
severity of emergence agitation
adverse effect from intravenous fentanyl prior the end of surgery
post operative pain
Full Information
NCT ID
NCT01440114
First Posted
September 22, 2011
Last Updated
September 22, 2011
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01440114
Brief Title
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
Official Title
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
Keywords
emergence agitation, pediatric patient, fentanyl, incidence of emergence agitation, severity of emergence agitation, adverse outcome from intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fentanyl group
Arm Type
Active Comparator
Arm 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.
Arm Title
controlled group
Arm Type
Placebo Comparator
Arm Description
patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
NSS
Intervention Description
Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.
Primary Outcome Measure Information:
Title
the incidence of emergence agitation
Time Frame
pt was observed since emerging from anesthesia up to 60 minutes
Secondary Outcome Measure Information:
Title
severity of emergence agitation
Time Frame
pt was observed since emerging from anesthesia up to 60 minutes
Title
adverse effect from intravenous fentanyl prior the end of surgery
Time Frame
pt was observed since emerging from anesthesia upto 60 minutes
Title
post operative pain
Time Frame
pt was observed since emerging from anesthesia up to 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hat-Yai
State/Province
Sonkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
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