Adjunctive Atropine During Ketamine Sedation

Conscious Sedation Clinical Trial

Official title:

Is Atropine Needed With Ketamine Sedation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834470
• Other study ID #: Atropine-01
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2009
• Last updated: August 3, 2012
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 10 Years

Eligibility

Inclusion Criteria:

• Pediatric lacerated patients

Exclusion Criteria:

• Contraindication of ketamine or atropine

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

Intervention

Drug:
• Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypersalivation(VAS)		During procedure	Yes
Secondary	Sedation scale		before, during procedure, before discharge	Yes
Secondary	Pain scale		before, during procedure, before discharge	Yes
Secondary	Complication		during procedure and bedore discharge and 1day after discharge	Yes
Secondary	Satisfaction of parents and clinicians		before discharge	Yes