A Phase 4 interventional study of Atropine in Conscious Sedation, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Months to 10 Years. Per ClinicalTrials.gov, last updated 2012-08-06.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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)
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atropine 0.01mg/kg IV
Drug: Atropine
Same volume of atropine
Drug: Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Hypersalivation(VAS)
Time frame: During procedure
Sedation scale
Time frame: before, during procedure, before discharge
Pain scale
Time frame: before, during procedure, before discharge
Complication
Time frame: during procedure and bedore discharge and 1day after discharge
Satisfaction of parents and clinicians
Time frame: before discharge
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital