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Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

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ClinicalTrials.gov Identifier: NCT02430272
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Won Joo Choe, Inje University

Tracking Information
First Submitted Date  ICMJE April 22, 2015
First Posted Date  ICMJE April 30, 2015
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2015)
Oral secretion (VAS) [ Time Frame: up to operative end ]
Oral secretion during the whole procedure was recorded by the researcher
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Official Title  ICMJE Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Fever
Intervention  ICMJE Drug: Glycopyrrolate
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
Study Arms  ICMJE
  • Experimental: Anticholinergic premedication
    Premedication with 0.005mg/Kg of glycopyrrolate
    Intervention: Drug: Glycopyrrolate
  • No Intervention: Control group
    Same volume of normal saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2015)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02430272
Other Study ID Numbers  ICMJE DSC-01-choe
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Won Joo Choe, Inje University
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Won Joo Choe, M.D. Ph.D Inje Univ.
PRS Account Inje University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP