Comparison of N2O Inhalation and Ketamine in Pediatric PSA
Brief 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 anxiolysis during primary repair of lacerated pediatric patients
Condition or Disease
- Moderate Sedation
- Laceration
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 36 Months to 10 Years |
| Enrollment: | 32 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
|
Clinical Trial Dates
| Start date: | Jan 01, 2009 | |
|---|---|---|
| Primary Completion: | Dec 01, 2009 | ACTUAL |
| Completion Date: | Dec 01, 2009 | ACTUAL |
| Study First Posted: | Feb 03, 2009 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Sep 13, 2011 |
Sponsors / Collaborators
Lead Sponsor:
Seoul National University Hospital
Lead sponsor is responsible party
Responsible Party:
N/A
Location
* 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
* 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
Participant Groups
-
Ketamine 2mg/kg IV
-
50%-70% N2O gas inhalation
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 3 |
| Maximum Age: | 10 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Pediatric patients with lacerated wound
Exclusion Criteria:
* Contraindication of ketamine or N2O gas
* A wound around eye and mouth
* Pediatric patients with lacerated wound
Exclusion Criteria:
* Contraindication of ketamine or N2O gas
* A wound around eye and mouth
Primary Outcomes
-
The recovery time (from completion of laceration repair to recovery of mental state) before discharge
Secondary Outcomes
-
Sedation scale before discharge
-
pain scale before discharge
-
Side effects during procedure and bedore discharge and 1day after discharge
-
Satisfaction of parents and clinicians before discharge
More Details
| NCT Number: | NCT00834730 |
|---|---|
| Acronym: | PSA |
| Other IDs: | N2O |
| Study URL: | https://clinicaltrials.gov/study/NCT00834730 |
Last updated: Sep 29, 2023