Skip to content

Adjunctive Atropine During Ketamine Sedation

Is Atropine Needed With Ketamine Sedation?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00834470
Enrollment
140
Registered
2009-02-03
Start date
2008-08-31
Completion date
2010-12-31
Last updated
2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious 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

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)

Interventions

DRUGAtropine

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 10 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric lacerated patients

Exclusion criteria

* Contraindication of ketamine or atropine

Design outcomes

Primary

MeasureTime frame
Hypersalivation(VAS)During procedure

Secondary

MeasureTime frame
Sedation scalebefore, during procedure, before discharge
Pain scalebefore, during procedure, before discharge
Complicationduring procedure and bedore discharge and 1day after discharge
Satisfaction of parents and cliniciansbefore discharge

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026