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Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01191398
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : March 20, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Craig J. Huang, University of Texas Southwestern Medical Center

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Sialorrhea Drug: Atropine (0.01mg/kg) Drug: Glycopyrrolate (0.01mg/kg) Drug: Normal saline 0.9% Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Study Start Date : June 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo and Ketamine
Normal Saline 0.9% will act as a placebo. Two ml of normal saline 0.9% will be administered intravenously 30 minutes prior to the administration of the ketamine.
 Drug: Normal saline 0.9%
Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine
Other Name: 0.9% Sodium Chloride
Active Comparator: Atropine and Ketamine
Atropine will be administered as a single dose of 0.01 mg/kg, with a minimum of dosage of 0.1 mg and a maximum dosage of 0.4 mg, intravenously 30 minutes before the administration of the ketamine.
 Drug: Atropine (0.01mg/kg)
Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Other Names:
  • AtroPen
  • Atropine sulfate
Active Comparator: Glycopyrrolate and Ketamine
Glycopyrrolate will be administered as a single dose of 0.01 mg/kg, with no minimum dosage and a maximum dose of 0.4 mg, intravenously 30 minutes before the administration of the ketamine.
 Drug: Glycopyrrolate (0.01mg/kg)
Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Other Name: Robinul


Outcome Measures
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Primary Outcome Measures :
  1. Difference in Salivary Flow Rate (ml/Min) Between Study Groups [ Time Frame: 30 minutes ]
    Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)


Secondary Outcome Measures :
  1. Monitoring of Adverse Events During Study Administration [ Time Frame: 1 hour ]
    Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191398


Locations
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United States, Texas
Children's Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Craig J. Huang
Investigators
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Study Chair: Adriana Rodriguez, MD UT Southwestern Medical Center
Principal Investigator: Craig Huang, MD UT Southwestern Medical Center
More Information
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Responsible Party: Craig J. Huang, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01191398    
Other Study ID Numbers: 012008-058
First Posted: August 30, 2010    Key Record Dates
Results First Posted: March 20, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014
Keywords provided by Craig J. Huang, University of Texas Southwestern Medical Center:
Hypersalivation
Conscious Sedation
Procedural Sedation
 Ketamine
Atropine
Glycopyrrolate
Additional relevant MeSH terms:
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Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Atropine
Glycopyrrolate
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action