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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

Tracking Information
First Submitted Date  ICMJE August 27, 2010
First Posted Date  ICMJE August 30, 2010
Results First Submitted Date  ICMJE December 11, 2013
Results First Posted Date  ICMJE March 20, 2014
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2010)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2010)
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 administred until at least 30 minutes post Ketamine administration.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Official Title  ICMJE Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Sialorrhea
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Normal saline 0.9%
  • 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.
    Intervention: Drug: Atropine (0.01mg/kg)
  • 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.
    Intervention: Drug: Glycopyrrolate (0.01mg/kg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2010)
54
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01191398
Other Study ID Numbers  ICMJE 012008-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig J. Huang, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE Craig J. Huang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Adriana Rodriguez, MD UT Southwestern Medical Center
Principal Investigator: Craig Huang, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP