search
Back to results

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

Primary Purpose

Sialorrhea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atropine (0.01mg/kg)
Glycopyrrolate (0.01mg/kg)
Normal saline 0.9%
Sponsored by
Craig J. Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sialorrhea focused on measuring Hypersalivation, Conscious Sedation, Procedural Sedation, Ketamine, Atropine, Glycopyrrolate

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo and Ketamine

Atropine and Ketamine

Glycopyrrolate and Ketamine

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
August 27, 2010
Last Updated
March 20, 2014
Sponsor
Craig J. Huang
search

1. Study Identification

Unique Protocol Identification Number
NCT01191398
Brief Title
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Official Title
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig J. Huang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sialorrhea
Keywords
Hypersalivation, Conscious Sedation, Procedural Sedation, Ketamine, Atropine, Glycopyrrolate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo and Ketamine
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Atropine and Ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Glycopyrrolate and Ketamine
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Atropine (0.01mg/kg)
Other Intervention Name(s)
AtroPen, Atropine sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate (0.01mg/kg)
Other Intervention Name(s)
Robinul
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline 0.9%
Other Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in Salivary Flow Rate (ml/Min) Between Study Groups
Description
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)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Monitoring of Adverse Events During Study Administration
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Rodriguez, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Craig Huang, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs