Trial Outcomes & Findings for Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation (NCT NCT01191398)

NCT ID: NCT01191398

Last Updated: 2014-04-16

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2014-04-16

Participant Flow

Participant milestones

Measure	Placebo 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 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 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 Study STARTED	17	17	18
Overall Study COMPLETED	17	17	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=17 Participants 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 n=17 Participants 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 n=18 Participants 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 n=52 Participants Total of all reporting groups
Age, Continuous	5.34 years STANDARD_DEVIATION 4.07 • n=5 Participants	5.09 years STANDARD_DEVIATION 3.76 • n=7 Participants	4.48 years STANDARD_DEVIATION 3.09 • n=5 Participants	4.85 years STANDARD_DEVIATION 3.01 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	18 participants n=5 Participants	52 participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Placebo n=17 Participants 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 n=17 Participants 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 n=18 Participants 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.
Difference in Salivary Flow Rate (ml/Min) Between Study Groups	.072 ml/min Standard Deviation 0.111	.003 ml/min Standard Deviation 0.0084	NA ml/min Standard Deviation NA No detectable measurable amount was collected, so mean and SD could not be calculated.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=17 Participants 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 n=17 Participants 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 n=18 Participants 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.
Monitoring of Adverse Events During Study Administration	1 adverse events	0 adverse events	0 adverse events

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Atropine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glycopyrrolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=17 participants at risk 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 n=17 participants at risk 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 n=18 participants at risk 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.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 • 9 months	0.00% 0/17 • 9 months	0.00% 0/18 • 9 months

Additional Information

Craig J. Huang, MD

University of Texas Southwestern Dallas Medical Center

Phone: 214-456-6371

Email: craig.huang@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place