Evaluation of nitrous oxide treatment given to children with procedural problems - a comparison with midazolam and the release of hormones
Completed
- Conditions
- Difficulties establishing intravenous accessSurgeryProcedural difficulties
- Registration Number
- ISRCTN33779750
- Lead Sponsor
- Frimurare Barnhuset Foundation (Stiftelsen Frimurare Barnhuset i Stockholm) (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Children (aged 5 - 18 years, either gender) with well known difficulties to establish intravenous access.
Exclusion Criteria
1. No ability to collaborate
2. Mental disturbance
3. Not fluent in Swedish
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of attempts that were required for double venous cannulation (number), 15 minutes after procedure<br>2. Child evaluation (Global Rating Scale GRS 1 - 5, where 1 = poor and 5 = excellent) recovery time (minutes), measured by finger tapping test 40 minutes before procedure and 15 minutes after procedure and if necessary every 15 minutes until the child had the same number of finger taps as before the procedure
- Secondary Outcome Measures
Name Time Method 1. Pain (Numeric Rating Scale [NRS] 0 - 10, where 0 = no pain and 10 = worst pain), evaluation by parent 15 minutes after procedure<br>2. Observer's Assessment of Alertness Sedation (OAA/S) scale 0 - 1, where 0 = deep asleep and 5 = alert), measured 30 minutes after procedure<br>3. Blood pressure, measured 40 minutes before the procedure, every 5 minutes during procedure, and 15 minutes after procedure and if necessary every 15 minutes after this<br>4. Heart rate, measured 40 minutes before the procedure, every 5 minutes during procedure, and 15 minutes after procedure and if necessary every 15 minutes after this<br>5. Saturation, measured 40 minutes before the procedure, every 5 minutes during procedure, and 15 minutes after procedure and if necessary every 15 minutes after this<br>6. Side effects, measured 40 minutes before the procedure, every 5 minutes during procedure, and 15 minutes after procedure and if necessary every 15 minutes after this