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

• 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: Craig J. Huang
• Information provided by (Responsible Party): Craig J. Huang, University of Texas Southwestern Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Sialorrhea
• Interventions: Drug: Atropine (0.01mg/kg); Drug: Glycopyrrolate (0.01mg/kg); Drug: Normal saline 0.9%
• Enrollment: 52

Participant Flow

Recruitment Details
Pre-assignment Details

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 Number of Baseline Participants		17	17	18	52
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	17 participants	17 participants	18 participants	52 participants
		5.34 (4.07)	5.09 (3.76)	4.48 (3.09)	4.85 (3.01)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	17 participants	18 participants	52 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; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	17 participants	17 participants	18 participants	52 participants
		17	17	18	52

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.
Overall Number of Participants Analyzed	17	17	18
Mean (Standard Deviation); Unit of Measure: ml/min
	.072 (0.111)	.003 (0.0084)	NA [1] (NA)

[1]

No detectable measurable amount was collected, so mean and SD could not be calculated.

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.
Overall Number of Participants Analyzed	17	17	18
Measure Type: Number; Unit of Measure: adverse events
	1	0	0

Adverse Events

Time Frame	9 months
Adverse Event Reporting 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.
All-Cause Mortality
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0.00%)		0/17 (0.00%)		0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Atropine		Glycopyrrolate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/17 (5.88%)		0/17 (0.00%)		0/18 (0.00%)
Gastrointestinal disorders
Vomiting † [1]	1/17 (5.88%)	1	0/17 (0.00%)	0	0/18 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] Episode of vomiting, post sedation. However, patient able to tolerate oral intake prior to hospital discharge.

Limitations and 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.

Results Point of Contact

• Name/Title: Craig J. Huang, MD
• Organization: University of Texas Southwestern Dallas Medical Center
• Phone: 214-456-6371
• EMail: craig.huang@utsouthwestern.edu

• Responsible Party: Craig J. Huang, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01191398
• Other Study ID Numbers: 012008-058
• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Results First Submitted: December 11, 2013
• Results First Posted: March 20, 2014
• Last Update Posted: April 16, 2014