Adjunctive Atropine During Ketamine Sedation

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation

Treatments: Drug: Atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT00834470

Atropine-01

Details and patient eligibility

About

• 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

Full 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)

Enrollment: 140 patients

Sex: All

Ages: 12 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric lacerated patients

Exclusion criteria

• Contraindication of ketamine or atropine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Atropine

Experimental group

Description:

Atropine 0.01mg/kg IV

Treatment:

Drug: Atropine

Normal saline

Placebo Comparator group

Description:

Same volume of atropine

Treatment:

Drug: Atropine