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Adjunctive Atropine During Ketamine Sedation

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StatusCompleted
Sponsors
Seoul National University Hospital

Keywords

Abstract

- 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

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)

Dates

Last Verified: 07/31/2012
First Submitted: 01/31/2009
Estimated Enrollment Submitted: 01/31/2009
First Posted: 02/02/2009
Last Update Submitted: 08/02/2012
Last Update Posted: 08/05/2012
Actual Study Start Date: 07/31/2008
Estimated Primary Completion Date: 11/30/2010
Estimated Study Completion Date: 11/30/2010

Condition or disease

Conscious Sedation

Intervention/treatment

Drug: Atropine

Phase

Phase 4

Arm Groups

ArmIntervention/treatment
Experimental: Atropine
Atropine 0.01mg/kg IV
Placebo Comparator: Normal saline
Same volume of atropine

Eligibility Criteria

Ages Eligible for Study 12 Months To 12 Months
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- Pediatric lacerated patients

Exclusion Criteria:

- Contraindication of ketamine or atropine

Outcome

Primary Outcome Measures

1. Hypersalivation(VAS) [During procedure]

Secondary Outcome Measures

1. Sedation scale [before, during procedure, before discharge]

2. Pain scale [before, during procedure, before discharge]

3. Complication [during procedure and bedore discharge and 1day after discharge]

4. Satisfaction of parents and clinicians [before discharge]

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