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

  • Atropine (DRUG)
    Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

Condition or Disease

  • Conscious Sedation

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 12 Months to 10 Years
    Enrollment: 140 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2008
    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

    Responsible Party: N/A

    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)

    Participant Groups

    • Atropine 0.01mg/kg IV

    • Same volume of atropine

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Pediatric lacerated patients

    Exclusion Criteria:

    * Contraindication of ketamine or atropine

    Primary Outcomes
    • Hypersalivation(VAS) During procedure
    Secondary Outcomes
    • 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

    More Details

    NCT Number: NCT00834470
    Other IDs: Atropine-01
    Study URL: https://clinicaltrials.gov/study/NCT00834470
    Last updated: Sep 29, 2023