Conscious Sedation Failure During ProcedurePhase 4NCT02205502
Lidocaine as Local Anesthetics in Children Under Ketamine Sedation
A Phase 4 study testing Lidocaine and Normal saline in people with Conscious Sedation Failure During Procedure and Analgesia, 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 in laceration repair. Lidocaine is the local anesthetics widespread used. Ketamine leads to dissociative amnesia. Theoretically , lidocaine is not useful in laceration repair using ketamine. Read more about this study
- Who is it for?
- Ages 12 months to 10 years
- Conditions the study is for
- Conscious Sedation Failure During Procedure, Analgesia, Anesthesia
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Oct 2018
- 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
- patients who need suturing for laceration under procedural anesthesia using ketamine
Who cannot join
- contraindication to ketamine and lidocaine
- patients involved to other studies
- more or equal to American Society of Anesthesiologist (ASA) class III
- not alert
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jin Hee Lee, Professor, +82-31-787-7586, gienee74@gmail.com
About this study
Official title: Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine
Ketamine seems an obvious choice in the setting of an emergency department in laceration repair.
Lidocaine is the local anesthetics widespread used.
Ketamine leads to dissociative amnesia.
Theoretically , lidocaine is not useful in laceration repair using ketamine.
However, lidocaine is used with ketamine in many emergency department.
The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure
- Being tested
- Lidocaine, Normal saline
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Proper amount of lidocaine will be injected lacerated wound.
* dosage form: fluid
* dosage: not exceeding 1mg/kg
* frequency: once
* duration: n/a Receives: Drug: Lidocaine |
| Normal saline | Placebo comparator | Normal saline will be used as a placebo for lidocaine Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.
Measured: up to 1 hour
Secondary outcomes (3)
Sedation scale
The investigators will measure sedation scale with Ramsey Sedation Scale.
Measured: up to 1 hour
Complication
The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.
Measured: up to 1 hour
Satisfaction of parents and clinicians
The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious Sedation Failure During ProcedureStudies 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
- 58 participants (estimated)
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 HospitalJin Hee Lee,, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205502
- Sponsor's protocol ID
- Lidocaine-01
- Status last verified
- Jan 2018
- First submitted
- 16 Jun 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine
- ClinicalTrials.gov ID
- NCT02205502
- Acronym / sponsor ID
- Lidocaine-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 31 Jul 2014 (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 in laceration repair.
Lidocaine is the local anesthetics widespread used.
Ketamine leads to dissociative amnesia.
Theoretically , lidocaine is not useful in laceration repair using ketamine.
However, lidocaine is used with ketamine in many emergency department.
The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure
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 |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineProper amount of lidocaine will be injected lacerated wound. * dosage form: fluid * dosage: not exceeding 1mg/kg * frequency: once * duration: n/a |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline will be used as a placebo for lidocaine |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients who need suturing for laceration under procedural anesthesia using ketamine
Key exclusion criteria (4 listed)
- contraindication to ketamine and lidocaine
- patients involved to other studies
- more or equal to American Society of Anesthesiologist (ASA) class III
- not alert
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 |
|---|---|---|
| LidocaineNormal saline will be injected subcutaneously as a placebo for lidocaine in study group of children. | Drug | Lidocaine |
| Normal saline | Drug | Normal saline |
Primary outcome
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
Time frame: up to 1 hour
The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.
3 secondary outcomes
Sedation scale
Time frame: up to 1 hour
Complication
Time frame: up to 1 hour
Satisfaction of parents and clinicians
Time frame: up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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
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 Lidocaine and Normal saline in people with Conscious Sedation Failure During Procedure and Analgesia, 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 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Hee Lee, Professor (+82-31-787-7575, gienee@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.