Moderate SedationPhase 4PSANCT00834730
Comparison of N2O Inhalation and Ketamine in Pediatric PSA
A Phase 4 study testing N2O gas vs ketamine in people with Moderate Sedation and Laceration, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and… Read more about this study
- Who is it for?
- Ages 36 months to 10 years
- Conditions the study is for
- Moderate Sedation, Laceration
- What is being tested?
- N2O gas vs ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2009
- 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 36 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with lacerated wound
Who cannot join
- Contraindication of ketamine or N2O gas
- A wound around eye and mouth
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: Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
- Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
- However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
- We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients
Read the detailed description
- There were 32 children who were randomly assigned
- Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)
- Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
- No difference was observed in the satisfaction scores by physicians, parents, or nurses.
- N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation
- Conditions
- Moderate Sedation, Laceration
- Being tested
- N2O gas vs ketamine
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N2O gas vs ketamineDrug
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Ketamine 2mg/kg IV Receives: Drug: N2O gas vs ketamine |
| N2O gas | Experimental | 50%-70% N2O gas inhalation Receives: Drug: N2O gas vs ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recovery time (from completion of laceration repair to recovery of mental state)
Measured: before discharge
Secondary outcomes (4)
Sedation scale
Measured: before discharge
pain scale
Measured: before discharge
Side effects
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 startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
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 Moderate 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Hee Lee, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834730
- Sponsor's protocol ID
- N2O
- Acronym
- PSA
- Status last verified
- Sep 2011
- First submitted
- 1 Feb 2009
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JH, Kim K, Kim TY, Jo YH, Kim SH, Rhee JE, Heo CY, Eun SC. A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. Pediatr Emerg Care. 2012 Dec;28(12):1297-301. doi: 10.1097/PEC.0b013e3182768a86.
PubMed 23187987
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
- ClinicalTrials.gov ID
- NCT00834730
- Acronym / sponsor ID
- PSA / N2O
- Conditions
- Moderate Sedation, Laceration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (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 provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
- However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
- We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients
Detailed description
- There were 32 children who were randomly assigned
- Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)
- Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
- No difference was observed in the satisfaction scores by physicians, parents, or nurses.
- N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: N2O gas vs ketamineKetamine 2mg/kg IV |
| N2O gas | Experimental | Drug: N2O gas vs ketamine50%-70% N2O gas inhalation |
Who may qualify
- Ages
- 36 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients with lacerated wound
Key exclusion criteria (2 listed)
- Contraindication of ketamine or N2O gas
- A wound around eye and mouth
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 |
|---|---|---|
| N2O gas vs ketamineKetamine : 2mg/kg IV N2O : 50%-70% N2O gas | Drug | Ketamine, N2O gas |
Primary outcome
The recovery time (from completion of laceration repair to recovery of mental state)
Time frame: before discharge
4 secondary outcomes
Sedation scale
Time frame: before discharge
pain scale
Time frame: before discharge
Side effects
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 15 Sep 2011.
- Derived from this study: PubMed 23187987Lee JH, Kim K, Kim TY, Jo YH, Kim SH, Rhee JE, Heo CY, Eun SC. A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. Pediatr Emerg Care. 2012 Dec;28(12):1297-301. doi: 10.1097/PEC.0b013e3182768a86.
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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 N2O gas vs ketamine in people with Moderate Sedation and Laceration, 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 2 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 15 Sep 2011. 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. 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?
The recovery time (from completion of laceration repair to recovery of mental state) (time frame: before discharge). 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 NCT00834730, 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 15 Sep 2011.