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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


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.


Minimum age: 6 Months. Maximum age: 18 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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