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 scalePain 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
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