Back to resultsAnticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Primary Purpose
Fever
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glycopyrrolate
Sponsored by
About this trial
This is an interventional prevention trial for Fever focused on measuring Child, outpatient, premedication
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Physical Status classification I
- underwent surgery between 8 to 9 am
- undergoing ambulatory anesthesia with ketamine
Exclusion Criteria:
- who required endotracheal intubation
- who were administered with medications other than ketamine
Sites / Locations
- Ilsan Paik hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anticholinergic premedication
Control group
Arm Description
Premedication with 0.005mg/Kg of glycopyrrolate
Same volume of normal saline
Outcomes
Primary Outcome Measures
Body temperature
measured body temperature at three times in both ears and the highest value was selected.
Secondary Outcome Measures
Oral secretion (VAS)
Oral secretion during the whole procedure was recorded by the researcher
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02430272
Brief Title
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Official Title
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
5. Study Description
Brief Summary
Anticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents.
The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
Child, outpatient, premedication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anticholinergic premedication
Arm Type
Experimental
Arm Description
Premedication with 0.005mg/Kg of glycopyrrolate
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Same volume of normal saline
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
Primary Outcome Measure Information:
Title
Body temperature
Description
measured body temperature at three times in both ears and the highest value was selected.
Time Frame
every 30 minutes from base line ( up to 90min )
Secondary Outcome Measure Information:
Title
Oral secretion (VAS)
Description
Oral secretion during the whole procedure was recorded by the researcher
Time Frame
up to operative end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) Physical Status classification I
underwent surgery between 8 to 9 am
undergoing ambulatory anesthesia with ketamine
Exclusion Criteria:
who required endotracheal intubation
who were administered with medications other than ketamine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Joo Choe, M.D. Ph.D
Organizational Affiliation
Inje Univ.
Official's Role
Study Chair
Facility Information:
Facility Name
Ilsan Paik hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27225859
Citation
Kim KW, Choe WJ, Kim JH, Kim KT, Lee SI, Park JS, Kim JW, Heo MH. Anticholinergic premedication-induced fever in paediatric ambulatory ketamine anaesthesia. J Int Med Res. 2016 Aug;44(4):817-23. doi: 10.1177/0300060515595649. Epub 2016 May 25.
Results Reference
derived
Learn more about this trial
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
We'll reach out to this number within 24 hrs