Clinical trial NCT00834470: Adjunctive Atropine During Ketamine Sedation
Official title: Is Atropine Needed With Ketamine Sedation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conscious Sedation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

* Pediatric lacerated patients

Exclusion Criteria:

* Contraindication of ketamine or atropine

Primary outcomes:
measure: Hypersalivation(VAS)
timeFrame: During procedure
Secondary outcomes:
measure: Sedation scale
timeFrame: before, during procedure, before discharge
measure: Pain scale
timeFrame: before, during procedure, before discharge
measure: Complication
timeFrame: during procedure and bedore discharge and 1day after discharge
measure: Satisfaction of parents and clinicians
timeFrame: before discharge
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin Hee Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.