Adjunctive Atropine During Ketamine Sedation
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
Intervention / Treatment
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Atropine (DRUG)Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Condition or Disease
- Conscious Sedation
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 12 Months to 10 Years |
Enrollment: | 140 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
Start date: | Aug 01, 2008 | |
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Primary Completion: | Dec 01, 2010 | ACTUAL |
Completion Date: | Dec 01, 2010 | ACTUAL |
Study First Posted: | Feb 03, 2009 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Aug 03, 2012 |
Sponsors / Collaborators
Lead Sponsor:
Seoul National University Hospital
Responsible Party:
N/A
Location
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)
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)
Participant Groups
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Atropine 0.01mg/kg IV
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Same volume of atropine
Eligibility Criteria
Sex: | All |
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Minimum Age: | 1 |
Maximum Age: | 10 |
Age Groups: | Child |
Healthy Volunteers: | Yes |
Inclusion Criteria:
* Pediatric lacerated patients
Exclusion Criteria:
* Contraindication of ketamine or atropine
* Pediatric lacerated patients
Exclusion Criteria:
* Contraindication of ketamine or atropine
Primary Outcomes
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Hypersalivation(VAS) During procedure
Secondary Outcomes
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Sedation scale before, during procedure, before discharge
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Pain scale before, during procedure, before discharge
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Complication during procedure and bedore discharge and 1day after discharge
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Satisfaction of parents and clinicians before discharge
More Details
NCT Number: | NCT00834470 |
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Other IDs: | Atropine-01 |
Study URL: | https://clinicaltrials.gov/study/NCT00834470 |
Last updated: Sep 29, 2023