Adjunctive Atropine During Ketamine Sedation

Phase 4

Completed

• Conditions: Conscious Sedation
• Interventions: Drug: Atropine

• Registration Number: NCT00834470
• Lead Sponsor: 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

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-01
• Study First Submitted QC: 2009-02-01
• Study First Posted: 2009-02-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Pediatric lacerated patients

Exclusion Criteria

• Contraindication of ketamine or atropine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine	Atropine	Atropine 0.01mg/kg IV
Normal saline	Atropine	Same volume of atropine

Primary Outcome Measures

Name	Time	Method
Hypersalivation(VAS)	During procedure

Secondary Outcome Measures

Name	Time	Method
Sedation scale	before, during procedure, before discharge
Pain scale	before, during procedure, before discharge
Complication	during procedure and bedore discharge and 1day after discharge
Satisfaction of parents and clinicians	before discharge

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of