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

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.

Study Overview

• Status: Completed
• Conditions: Sialorrhea
• Intervention / Treatment: Drug: Normal saline 0.9%; Drug: Atropine (0.01mg/kg); Drug: Glycopyrrolate (0.01mg/kg)

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Children's Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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: Atropine sulfate; AtroPen
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 Names: Robinul

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Salivary Flow Rate (ml/Min) Between Study Groups	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)	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring of Adverse Events During Study Administration	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.	1 hour

Collaborators and Investigators

• Sponsor: Craig J. Huang
• Investigators: Study Chair: Adriana Rodriguez, MD, UT Southwestern Medical Center; Principal Investigator: Craig Huang, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Ketamine; Hypersalivation; Conscious Sedation; Atropine; Procedural Sedation; Glycopyrrolate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Sialorrhea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Glycopyrrolate; Atropine
• Other Study ID Numbers: 012008-058