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Adjunctive Atropine During Ketamine Sedation

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ClinicalTrials.gov Identifier: NCT00834470
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Conscious Sedation Drug: Atropine Phase 4

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)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Atropine Needed With Ketamine Sedation?
Study Start Date : August 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hypersalivation(VAS) [ Time Frame: During procedure ]

Secondary Outcome Measures :
  1. Sedation scale [ Time Frame: before, during procedure, before discharge ]
  2. Pain scale [ Time Frame: before, during procedure, before discharge ]
  3. Complication [ Time Frame: during procedure and bedore discharge and 1day after discharge ]
  4. Satisfaction of parents and clinicians [ Time Frame: before discharge ]


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Ages Eligible for Study:   12 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric lacerated patients

Exclusion Criteria:

  • Contraindication of ketamine or atropine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Ketamine
Atropine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents