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

• Sponsor: Craig J. Huang (Other)
• Overall Status: Completed
• CT.gov ID: NCT01191398
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 7.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sialorrhea	Drug: Atropine (0.01mg/kg); Drug: Glycopyrrolate (0.01mg/kg); Drug: Normal saline 0.9%	N/A

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

• Study Type: Interventional
• 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: Jun 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

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: 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 Names: Robinul

Outcome Measures

Primary Outcome Measures

1. Difference in Salivary Flow Rate (ml/Min) Between Study Groups [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 [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

Criteria

• Ages Eligible for Study: 6 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Medical Center at Dallas	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Craig J. Huang

Investigators

• Study Chair: Adriana Rodriguez, MD, UT Southwestern Medical Center
• Principal Investigator: Craig Huang, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 30, 2010
• Last Update Posted: Apr 16, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Craig J. Huang, Associate Professor, University of Texas Southwestern Medical Center: Hypersalivation; Conscious Sedation; Procedural Sedation; Ketamine; Atropine; Glycopyrrolate
• Additional relevant MeSH terms: Sialorrhea; Atropine; Glycopyrrolate

Study Results

Participant Flow

Arm/Group Title	Placebo	Atropine	Glycopyrrolate
Arm/Group Description	Normal Saline0.9% will act as a placebo. Placebo: 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	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.	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.
Period Title: Overall Study
STARTED	17	17	18
COMPLETED	17	17	18
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Atropine	Glycopyrrolate	Total
Arm/Group Description	Normal Saline0.9% will act as a placebo. Placebo: 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	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.	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.	Total of all reporting groups
Overall Participants	17	17	18	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.34 (4.07)	5.09 (3.76)	4.48 (3.09)	4.85 (3.01)
Sex: Female, Male (Count of Participants)
Female	6 35.3%	8 47.1%	11 61.1%	25 48.1%
Male	11 64.7%	9 52.9%	7 38.9%	27 51.9%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	18 100%	52 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Atropine	Glycopyrrolate
Arm/Group Description	Normal Saline0.9% will act as a placebo. Placebo: 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	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.	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.
Measure Participants	17	17	18
Mean (Standard Deviation) [ml/min]	.072 (0.111)	.003 (0.0084)	NA (NA)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Atropine	Glycopyrrolate
Arm/Group Description	Normal Saline0.9% will act as a placebo. Placebo: 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	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.	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.
Measure Participants	17	17	18
Number [adverse events]	1	0	0

Adverse Events

Time Frame	9 months
Arm/Group Title	Placebo		Atropine		Glycopyrrolate
Arm/Group Description	Normal Saline0.9% will act as a placebo. Placebo: 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		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.		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.
All Cause Mortality
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)		0/17 (0%)		0/18 (0%)
Gastrointestinal disorders
Vomiting	1/17 (5.9%)	1	0/17 (0%)	0	0/18 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.