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

Tracking Information

First Received Date ^ICMJE

February 1, 2009

Last Updated Date

August 3, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00834470 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Enrollment ^ICMJE

140

Completion Date

December 2010

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

Gender

Both

Ages

12 Months to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00834470

Other Study ID Numbers ^ICMJE

Atropine-01

Has Data Monitoring Committee

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

Information Provided By

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

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