Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
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|ClinicalTrials.gov Identifier: NCT01191398|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : March 20, 2014
Last Update Posted : April 16, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Sialorrhea||Drug: Atropine (0.01mg/kg) Drug: Glycopyrrolate (0.01mg/kg) Drug: Normal saline 0.9%||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|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|
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.
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
- 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)
- 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.
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|Ages Eligible for Study:||6 Months to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Texas|
|Children's Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Adriana Rodriguez, MD||UT Southwestern Medical Center|
|Principal Investigator:||Craig Huang, MD||UT Southwestern Medical Center|
|Responsible Party:||Craig J. Huang, Associate Professor, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 30, 2010 Key Record Dates|
|Results First Posted:||March 20, 2014|
|Last Update Posted:||April 16, 2014|
|Last Verified:||March 2014|
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