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Adjunctive Atropine During Ketamine Sedation

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Conscious Sedation

Intervention: Atropine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jin Hee Lee, Professor, Principal Investigator, Affiliation: Seoul National University Bundang Hospital

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 Details

Official title: Is Atropine Needed With Ketamine Sedation?

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

Primary outcome: Hypersalivation(VAS)

Secondary outcome:

Sedation scale

Pain scale

Complication

Satisfaction of parents and clinicians

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)

Eligibility

Minimum age: 12 Months. Maximum age: 10 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pediatric lacerated patients

Exclusion Criteria:

- Contraindication of ketamine or atropine

Locations and Contacts

Seoul National University Bundang Hospital, Gyeonggi-do 463-707, Korea, Republic of
Additional Information

Starting date: August 2008
Last updated: August 3, 2012

Page last updated: August 20, 2015

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