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

NCT01191398 | Completed Results

• 1 other identifier: 012008-058
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sialorrhea

Keywords

Hypersalivation; Conscious Sedation; Procedural Sedation; Ketamine; Atropine; Glycopyrrolate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Monitoring of Adverse Events During Study Administration

  1 hour

Study Arms (3)

Placebo and Ketamine

PLACEBO COMPARATOR

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%

Atropine and Ketamine

ACTIVE COMPARATOR

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)

Glycopyrrolate and Ketamine

ACTIVE COMPARATOR

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)

Interventions

Atropine (0.01mg/kg) DRUG

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.

Also known as: AtroPen, Atropine sulfate

Atropine and Ketamine

Glycopyrrolate (0.01mg/kg) DRUG

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.

Also known as: Robinul

Glycopyrrolate and Ketamine

Normal saline 0.9% DRUG

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

Also known as: 0.9% Sodium Chloride

Placebo and Ketamine

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig J. Huang: lead

Study Sites (1)

Children's Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Sialorrhea

Interventions

Atropine; Glycopyrrolate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Craig J. Huang, MD
• Organization: University of Texas Southwestern Dallas Medical Center

craig.huang@utsouthwestern.edu

214-456-6371

Study Officials

• Adriana Rodriguez, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Craig Huang, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 16, 2014
• Results First Posted: March 20, 2014

Record last verified: 2014-03

Locations

US (1)