Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
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Purpose
The purpose of this study is to determine if the antisialogogues (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.
| Condition | Intervention |
|---|---|
|
Sialorrhea Conscious Sedation |
Drug: Atropine (0.01mg/kg) Drug: Glycopyrrolate (0.01mg/kg) Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation |
- Difference in Salivary Flow Rate (ml/min) between study groups [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]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)
- Monitoring of adverse events during study administration [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 54 |
| Study Start Date: | June 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Normal Saline0.9% will act as a placebo.
|
Drug: 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
|
| Active Comparator: Atropine |
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.
|
| Active Comparator: Glycopyrrolate |
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.
Other Name: Robinul
|
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| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Texas | |
| Children's Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| Study Chair: | Adriana Rodriguez, MD | UT Southwestern Medical Center |
| Principal Investigator: | Craig Huang, MD | UT Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | Craig Huang, MD, UT Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01191398 History of Changes |
| Other Study ID Numbers: | 012008-058 |
| Study First Received: | August 27, 2010 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Hypersalivation Conscious Sedation Ketamine Atropine Glycopyrrolate |
Additional relevant MeSH terms:
|
Sialorrhea Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Atropine Glycopyrrolate Ketamine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Cardiovascular Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on October 17, 2012
