N/A
N=52
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Sialorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01191398 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Difference in Salivary Flow Rate (ml/Min) Between Study Groups — .072; .003; NA ml/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atropine (0.01mg/kg) (Drug); Glycopyrrolate (0.01mg/kg) (Drug); Normal saline 0.9% (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Craig J. Huang
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Salivary Flow Rate (ml/Min) Between Study Groups |
.072; .003; NA | — |
| SECONDARY Monitoring of Adverse Events During Study Administration |
1; 0; 0 | — |
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 procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01191398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.