Conscious SedationPhase 4NCT00834470
Adjunctive Atropine During Ketamine Sedation
A Phase 4 study testing Atropine in people with Conscious Sedation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months to 10 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric lacerated patients
Who cannot join
- Contraindication of ketamine or atropine
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Gyeonggi-do, 463-707
About this study
Official title: Is Atropine Needed With Ketamine Sedation?
- 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
Read the 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
- Being tested
- Atropine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Atropine | Experimental | Atropine 0.01mg/kg IV Receives: Drug: Atropine |
| Normal saline | Placebo comparator | Same volume of atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersalivation(VAS)
Measured: During procedure
Secondary outcomes (4)
Sedation scale
Measured: before, during procedure, before discharge
Pain scale
Measured: before, during procedure, before discharge
Complication
Measured: during procedure and bedore discharge and 1day after discharge
Satisfaction of parents and clinicians
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hee Lee, Seoul National University Hospital
- Investigators
- Jin Hee Lee, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834470
- Sponsor's protocol ID
- Atropine-01
- Status last verified
- Aug 2012
- First submitted
- 1 Feb 2009
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22748697
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Atropine Needed With Ketamine Sedation?
- ClinicalTrials.gov ID
- NCT00834470
- Acronym / sponsor ID
- Atropine-01
- Conditions
- Conscious Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine | Experimental | Drug: AtropineAtropine 0.01mg/kg IV |
| Normal saline | Placebo comparator | Drug: AtropineSame volume of atropine |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric lacerated patients
Key exclusion criteria (1 listed)
- Contraindication of ketamine or atropine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineKetamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline | Drug | Atropine, Normal saline |
Primary outcome
Hypersalivation(VAS)
Time frame: During procedure
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 22748697Kye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Hee Lee, Professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine in people with Conscious Sedation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersalivation(VAS) (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.