Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Fever Clinical Trial

Official title:

Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430272
• Other study ID #: DSC-01-choe
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 29, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• Glycopyrrolate
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group

Locations

Country	Name	City	State
Korea, Republic of	Ilsan Paik hospital	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	No
Secondary	Oral secretion (VAS)	Oral secretion during the whole procedure was recorded by the researcher	up to operative end	No