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Completed

NCT Number: NCT00834470

Adjunctive Atropine During Ketamine Sedation

* 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

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Key information

Conditions

Age range

12 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric lacerated patients

Exclusion criteria

  • Contraindication of ketamine or atropine

Treatment and study plan

Atropine

Drug

Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

Primary outcomes

  1. Hypersalivation(VAS)

    Time frame: During procedure

Secondary outcomes

  1. Sedation scale

    Time frame: before, during procedure, before discharge

  2. Pain scale

    Time frame: before, during procedure, before discharge

  3. Complication

    Time frame: during procedure and bedore discharge and 1day after discharge

  4. Satisfaction of parents and clinicians

    Time frame: before discharge

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Is Atropine Needed With Ketamine Sedation?

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2009
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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