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
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