Anticholinergic Premedication Induced Fever in Pediatric... | NCT02430272

Studies
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

NCT02430272

Sponsor

Inje University

Status

Completed

Last Update Posted

May 1, 2015Estimated

Enrollment

84Actual

Phase

Not Applicable

Conditions

Fever

Interventions

Glycopyrrolate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Apr 25, 2015

First Posted Date

Apr 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2015

Last Update Posted Date

May 1, 2015Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anticholinergic premedication	Experimental	Premedication with 0.005mg/Kg of glycopyrrolate	Drug: Glycopyrrolate
Control group	No Intervention	Same volume of normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glycopyrrolate	Drug	Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group	Anticholinergic premedication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Won Joo Choe, M.D. Ph.D	Inje Univ.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ilsan Paik hospital		Goyang-si	Gyeonggi-do	411-706	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27225859	Derived	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.

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds