Adjunctive Atropine During Ketamine Sedation

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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Is Atropine Needed With Ketamine Sedation?

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: Atropine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric lacerated patients Exclusion Criteria: Contraindication of ketamine or atropine

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine<br>Atropine 0.01mg/kg IV | Drug: Atropine<br>* Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline<br>|
| Placebo Comparator: Normal saline<br>Same volume of atropine | Drug: Atropine<br>* Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersalivation(VAS) |  | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |