Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sialorrhea
Intervention: Atropine (0.01mg/kg) (Drug); Glycopyrrolate (0.01mg/kg) (Drug); Normal saline 0.9% (Drug)
Phase: N/A
Status: Completed
Sponsored by: Craig J. Huang Official(s) and/or principal investigator(s): Adriana Rodriguez, MD, Study Chair, Affiliation: UT Southwestern Medical Center Craig Huang, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center
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.
Clinical Details
Official title: Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Difference in Salivary Flow Rate (ml/Min) Between Study Groups
Secondary outcome: Monitoring of Adverse Events During Study Administration
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 hypersalivation, potentially leading to laryngospasms. To prevent hypersalivation (and
reduce the potential for laryngospasms), an anti-salivary agent, such as Atropine, is
commonly given in combination with Ketamine. Recently, however, the necessity of this
practice has been brought into question. The consideration of using a different drug,
glycopyrrolate, has been debated. The purpose of this study is to compare the effectiveness
of each medication in addition to the placebo control.
Patients enrolled into this study must present to the emergency department or abscess clinic
with the need to receive Ketamine as part of a sedation procedure (as determined by the
treating physician). This study will randomize enrolled patients to receive double-blinded
Atropine, Glycopyrrolate or placebo given 30 minutes prior to Ketamine. After Ketamine is
administered, a trained medical person will suction the patient's mouth every 5 minutes for
a total of 30 minutes, collecting all oral secretions. Total saliva production will be
measured and salivary flow rates will be calculated and compared between each assigned
group. Adverse events and complications will be monitored throughout the patient's stay in
the emergency department or abscess clinic.
Eligibility
Minimum age: 6 Months.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Children's Medical Center at Dallas, Dallas, Texas 75390, United States
Additional Information
Starting date: June 2010
Last updated: March 20, 2014
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