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Adjunctive Atropine During Ketamine Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00834470
First received: February 1, 2009
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose
  • Ketamine seems an obvious choice in the setting of an emergency department
  • Ketamine leads to increased production of salivary and tracheal secretions
  • Antisialagogues(atropine)therefore have been recommended as a routine adjunct
  • We compare atropine with placebo as an adjunct to ketamine sedation in children undergoing primary closure of lacerated wound

Condition Intervention Phase
Conscious Sedation
 Drug: Atropine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Atropine Needed With Ketamine Sedation?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Hypersalivation(VAS) [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sedation scale [ Time Frame: before, during procedure, before discharge ] [ Designated as safety issue: Yes ]
  • Pain scale [ Time Frame: before, during procedure, before discharge ] [ Designated as safety issue: Yes ]
  • Complication [ Time Frame: during procedure and bedore discharge and 1day after discharge ] [ Designated as safety issue: Yes ]
  • Satisfaction of parents and clinicians [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atropine
Atropine 0.01mg/kg IV
 Drug: Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Placebo Comparator: Normal saline
Same volume of atropine
 Drug: Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

Detailed Description:

The degree of secretion was significantly less in the atropine group compared with the control group at the end of the procedure (VAS score: 16.5 ± 9.9 vs. 27.0 ± 15.9, atropine vs. control, p = 0.00). The change in the degree of secretion between the start and end of the procedure was significantly greater in the atropine group than in the control group (p = 0.00) (Fig. 2). However, the frequency of hypersalivation as predefined (VAS score ≥50) did not differ between the groups (p = 0.06).

The only complication that differed significantly between the two groups was tachycardia (p > 0.05). Complications such as aspiration, laryngospasm, and apnea were not documented in the hospital. There were fewer interventions for hypersalivation in the atropine group, but the difference was not significant (p > 0.05). As interventions, O2 administration and endotracheal intubation were not needed. After discharge, the control patients tended to have more complaints of nausea, vomiting, and ataxia, although the difference was not significant (p > 0.05) Heart rate was increased significantly in the atropine group (p = 0.00). The frequency of tachycardia according to patient age was also significantly higher in the atropine group than in the control group (p = 0.00)

  Eligibility

Ages Eligible for Study:   12 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric lacerated patients

Exclusion Criteria:

  • Contraindication of ketamine or atropine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834470

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin Hee Lee, Professor Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jin Hee Lee, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00834470     History of Changes
Other Study ID Numbers: Atropine-01
Study First Received: February 1, 2009
Last Updated: August 3, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Atropine
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
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on June 18, 2013