Adjunctive Atropine During Ketamine Sedation

Conscious Sedation Clinical Trial

Official title: Is Atropine Needed With Ketamine Sedation?

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conscious Sedation

• NCT number: NCT00834470
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: August 2008
• Completion date: December 2010