FeverNCT02430272
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
A study testing Glycopyrrolate in people with Fever, run by Inje University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- Fever
- What is being tested?
- Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status classification I
- underwent surgery between 8 to 9 am
- undergoing ambulatory anesthesia with ketamine
Who cannot join
- who required endotracheal intubation
- who were administered with medications other than ketamine
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fever
- Being tested
- Glycopyrrolate
- Keywords
- Child, outpatient, premedication
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic premedication | Experimental | Premedication with 0.005mg/Kg of glycopyrrolate Receives: Drug: Glycopyrrolate |
| Control group | No intervention | Same volume of normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
measured body temperature at three times in both ears and the highest value was selected.
Measured: every 30 minutes from base line ( up to 90min )
Secondary outcomes (1)
Oral secretion (VAS)
Oral secretion during the whole procedure was recorded by the researcher
Measured: up to operative end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Joo Choe, Inje University
- Investigators
- Won Joo Choe, M.D. Ph.D, Study chair, Inje Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430272
- Sponsor's protocol ID
- DSC-01-choe
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2015
- Last updated
- 1 May 2015
- Results posted
- No
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.
PubMed 27225859
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
- ClinicalTrials.gov ID
- NCT02430272
- Acronym / sponsor ID
- DSC-01-choe
- Conditions
- Fever
- Keywords
- Child, outpatient, premedication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticholinergic premedication | Experimental | Drug: GlycopyrrolatePremedication with 0.005mg/Kg of glycopyrrolate |
| Control group | No intervention | –Same volume of normal saline |
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Physical Status classification I
- underwent surgery between 8 to 9 am
- undergoing ambulatory anesthesia with ketamine
Key exclusion criteria (2 listed)
- who required endotracheal intubation
- who were administered with medications other than ketamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrrolateIntravenously administered 0.005mg/Kg of glycopyrrolate in intervention group | Drug | Anticholinergic premedication |
Primary outcome
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.
1 secondary outcome
Oral secretion (VAS)
Time frame: up to operative end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Derived from this study: PubMed 27225859Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Joo Choe, M.D. Ph.D study chair
Inje Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycopyrrolate in people with Fever, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: every 30 minutes from base line ( up to 90min )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.