Clinical trial NCT01191398: Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Official title: Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sialorrhea
Keywords: Hypersalivation
Conscious Sedation
Procedural Sedation
Ketamine
Atropine
Glycopyrrolate
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Difference in Salivary Flow Rate (ml/Min) Between Study Groups
timeFrame: 30 minutes
Secondary outcomes:
measure: Monitoring of Adverse Events During Study Administration
timeFrame: 1 hour
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Adriana Rodriguez, MD
role: STUDY_CHAIR
affiliation: UT Southwestern Medical Center
name: Craig Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: