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

Sialorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191398
• Other study ID #: 012008-058
• Status: Completed
• Phase: N/A
• First received: August 27, 2010
• Last updated: March 20, 2014
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sialorrhea

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Children's Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Craig J. Huang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes