Status:
COMPLETED
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Lead Sponsor:
Craig J. Huang
Conditions:
Sialorrhea
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for...
Detailed Description
Ketamine is a common sedation agent used in the pediatric emergency department for a variety of procedures, used in clinical practice since 1970. One potential side effect of Ketamine is hypersalivati...
Eligibility Criteria
Inclusion
- Children age 6 months to 18 years (inclusive) presenting to Children's Medical Center Emergency Department or Abscess Clinic.
- Children whom the attending physician feels need procedural sedation with the intravenous medication, Ketamine.
Exclusion
- Children who are ASA class III or greater.
- Children with an allergy or contraindication to ketamine, atropine or glycopyrrolate.
- Inability to tolerate oral suctioning.
- Any condition or situation whereby the patient would be unable to have his/her head turned to one side.
- Patient history of vomiting or diarrhea in the last 24 hours
- Patients who have taken an anti-sialogogue within the previous 24 hours.
- Patients that need to receive Midazolam or other benzodiazepines.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01191398
Start Date
June 1 2010
End Date
January 1 2011
Last Update
April 16 2014
Active Locations (1)
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1
Children's Medical Center at Dallas
Dallas, Texas, United States, 75390