Evaluation of nitrous oxide treatment given to children with procedural problems - a comparison with midazolam and the release of hormones
| ISRCTN | ISRCTN33779750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33779750 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/11/2008
- Registration date
- 16/01/2009
- Last edited
- 24/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claude Marcus
Scientific
Scientific
Division of Pediatrics, CLINTEC
Karolinska Institutet
Division of Endocrinology, Diabetes and Metabolism
National Childhood Obesity Centre
Karolinska University Hospital
Stockholm
14186
Sweden
| claude.marcus@ki.se |
Study information
| Study design | Prospective double-blind randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of nitrous oxide treatment given to children with procedural problems - a comparison with midazolam and the release of hormones: a prospective double-blind randomised study |
| Study objectives | Is nitrous oxide treatment improving patient care in the out-patient paediatric departments compared to midazolam? |
| Ethics approval(s) | Ethical Committee of South Stockholm gave approval on the 14th January 2005 (ref: 050114) |
| Health condition(s) or problem(s) studied | Difficulties establishing intravenous access |
| Intervention | Evaluation of nitrous oxide treatment and midazolam given to children with procedural problems, comparing three different methods of treatment: 1. Midazolam 0.3 mg/kg maximum 15 mg per os oxygen for inhalation (n = 30) 2. 50% nitrous oxide 50% oxygen for inhalation (n = 30) 3. 10% nitrous oxide (placebo) 90 % oxygen (n = 30) All 90 children had 15 ml syrup with or without midazolam and after 40 minutes all children were breathing into a mask with or without nitrous 3 minutes before, during and 3 minutes after venous cannulation. All children were followed up at least 4 hour after the treatments. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitrous oxide, midazolam |
| Primary outcome measure | 1. Number of attempts that were required for double venous cannulation (number), 15 minutes after procedure 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 | 1. Pain (Numeric Rating Scale [NRS] 0 - 10, where 0 = no pain and 10 = worst pain), evaluation by parent 15 minutes after procedure 2. Observer's Assessment of Alertness Sedation (OAA/S) scale 0 - 1, where 0 = deep asleep and 5 = alert), measured 30 minutes after procedure 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 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 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 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 |
| Overall study start date | 01/04/2005 |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Children (aged 5 - 18 years, either gender) with well known difficulties to establish intravenous access. |
| Key exclusion criteria | 1. No ability to collaborate 2. Mental disturbance 3. Not fluent in Swedish |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/12/2008 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Division of Pediatrics, CLINTEC
Stockholm
14186
Sweden
14186
Sweden
Sponsor information
Frimurare Barnhuset Foundation (Stiftelsen Frimurare Barnhuset i Stockholm) (Sweden)
Research organisation
Research organisation
Nybrokajen 7
Stockholm
111 48
Sweden
| sfbs@frimurarorden.se | |
| Website | http://www.frimurarorden.se/ |
Funders
Funder type
Hospital/treatment centre
Childrens Hospital Karolinska University Hospital Huddinge Stockholm (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | results | 01/09/2012 | Yes | No |
