Adjunctive Atropine During Ketamine Sedation

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00834470

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: Atropine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Is Atropine Needed With Ketamine Sedation?

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atropine Atropine 0.01mg/kg IV	Drug: Atropine Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Placebo Comparator: Normal saline Same volume of atropine	Drug: Atropine Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

Arm

Intervention/Treatment

Experimental: Atropine

Atropine 0.01mg/kg IV

Drug: Atropine

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

Placebo Comparator: Normal saline

Same volume of atropine

Drug: Atropine

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

Outcome Measures

Primary Outcome Measures

Hypersalivation(VAS) [During procedure]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pediatric lacerated patients

Exclusion Criteria:

Contraindication of ketamine or atropine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Gyeonggi-do		Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jin Hee Lee, Professor, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin Hee Lee, Assistant professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00834470

Other Study ID Numbers:

Atropine-01

First Posted:

Feb 3, 2009

Last Update Posted:

Aug 6, 2012

Last Verified:

Aug 1, 2012

Additional relevant MeSH terms:

Atropine

Study Results

No Results Posted as of Aug 6, 2012