Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

April 29, 2015 updated by: Won Joo Choe, Inje University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
        • Ilsan Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 30 minutes from base line ( up to 90min )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral secretion (VAS)
Time Frame: up to operative end
Oral secretion during the whole procedure was recorded by the researcher
up to operative end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Study Chair: Won Joo Choe, M.D. Ph.D, Inje Univ.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 25, 2015

First Posted (ESTIMATE)

April 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSC-01-choe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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