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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

Tracking Information
First Submitted Date  ICMJE February 1, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date August 6, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2009)
Hypersalivation(VAS) [ Time Frame: During procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2009)
  • Sedation scale [ Time Frame: before, during procedure, before discharge ]
  • Pain scale [ Time Frame: before, during procedure, before discharge ]
  • Complication [ Time Frame: during procedure and bedore discharge and 1day after discharge ]
  • Satisfaction of parents and clinicians [ Time Frame: before discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Atropine During Ketamine Sedation
Official Title  ICMJE Is Atropine Needed With Ketamine Sedation?
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Conscious Sedation
Intervention  ICMJE Drug: Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Study Arms  ICMJE
  • Experimental: Atropine
    Atropine 0.01mg/kg IV
    Intervention: Drug: Atropine
  • Placebo Comparator: Normal saline
    Same volume of atropine
    Intervention: Drug: Atropine
Publications * Kye YC, Rhee JE, Kim K, Kim T, Jo YH, Jeong JH, Lee JH. Clinical effects of adjunctive atropine during ketamine sedation in pediatric emergency patients. Am J Emerg Med. 2012 Nov;30(9):1981-5. doi: 10.1016/j.ajem.2012.04.030. Epub 2012 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2009)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pediatric lacerated patients

Exclusion Criteria:

  • Contraindication of ketamine or atropine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00834470
Other Study ID Numbers  ICMJE Atropine-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Hee Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Hee Lee, Professor Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP