Adjunctive Atropine During Ketamine Sedation

NCT ID: NCT00834470

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-12-31

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)

Conditions

Conscious Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atropine

Atropine 0.01mg/kg IV

Group Type: EXPERIMENTAL

Atropine

Intervention Type: DRUG

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

Normal saline

Same volume of atropine

Group Type: PLACEBO_COMPARATOR

Atropine

Intervention Type: DRUG

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

Interventions

Atropine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pediatric lacerated patients

Exclusion Criteria

• Contraindication of ketamine or atropine

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Hee Lee

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Hee Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Countries

South Korea

References

Kye YC, Rhee JE, Kim K, Kim T, Jo YH, Jeong JH, Lee JH. Clinical effects of adjunctive atropine during ketamine sedation in pediatric emergency patients. Am J Emerg Med. 2012 Nov;30(9):1981-5. doi: 10.1016/j.ajem.2012.04.030. Epub 2012 Jun 28.

Reference Type: DERIVED

PMID: 22748697 (View on PubMed)

Other Identifiers

Atropine-01

Identifier Type: -

Identifier Source: org_study_id