Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedMay 1, 2015
April 1, 2015
6 months
April 22, 2015
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body temperature
measured body temperature at three times in both ears and the highest value was selected.
every 30 minutes from base line ( up to 90min )
Secondary Outcomes (1)
Oral secretion (VAS)
up to operative end
Study Arms (2)
Anticholinergic premedication
EXPERIMENTALPremedication with 0.005mg/Kg of glycopyrrolate
Control group
NO INTERVENTIONSame volume of normal saline
Interventions
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) Physical Status classification I
- underwent surgery between 8 to 9 am
- undergoing ambulatory anesthesia with ketamine
You may not qualify if:
- who required endotracheal intubation
- who were administered with medications other than ketamine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
Study Sites (1)
Ilsan Paik hospital
Goyang-si, Gyeonggi-do, 411-706, South Korea
Related Publications (1)
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.
PMID: 27225859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Won Joo Choe, M.D. Ph.D
Inje Univ.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D., Associate professor,
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 30, 2015
Study Start
May 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
May 1, 2015
Record last verified: 2015-04