Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2008-08-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Atropine
Atropine 0.01mg/kg IV
Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Normal saline
Same volume of atropine
Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atropine
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
12 Months
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jin Hee Lee
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jin Hee Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Atropine-01
Identifier Type: -
Identifier Source: org_study_id