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

NCT ID: NCT01191398

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-01-31

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.

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.

Conditions

Sialorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline 0.9%

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Atropine (0.01mg/kg)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Glycopyrrolate (0.01mg/kg)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

AtroPen; Atropine sulfate; Robinul; 0.9% Sodium Chloride

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig J. Huang

OTHER

Sponsor Role: lead

Responsible Party

Craig J. Huang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adriana Rodriguez, MD

Role: STUDY_CHAIR

UT Southwestern Medical Center

Craig Huang, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Children's Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

012008-058

Identifier Type: -

Identifier Source: org_study_id