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Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02430272
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : May 1, 2015
Information provided by (Responsible Party):
Won Joo Choe, Inje University

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.

Condition or disease Intervention/treatment Phase
Fever Drug: Glycopyrrolate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Anticholinergic premedication
Premedication with 0.005mg/Kg of glycopyrrolate
Drug: Glycopyrrolate
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group

No Intervention: Control group
Same volume of normal saline

Primary Outcome Measures :
  1. Body temperature [ Time Frame: every 30 minutes from base line ( up to 90min ) ]
    measured body temperature at three times in both ears and the highest value was selected.

Secondary Outcome Measures :
  1. Oral secretion (VAS) [ Time Frame: up to operative end ]
    Oral secretion during the whole procedure was recorded by the researcher

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02430272

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Korea, Republic of
Ilsan Paik hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
Sponsors and Collaborators
Inje University
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Study Chair: Won Joo Choe, M.D. Ph.D Inje Univ.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Won Joo Choe, M.D., Ph.D., Associate professor,, Inje University Identifier: NCT02430272    
Other Study ID Numbers: DSC-01-choe
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Won Joo Choe, Inje University:
Additional relevant MeSH terms:
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Body Temperature Changes
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs