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 |
| Protocol serial number | N/A |
| Sponsor | Frimurare Barnhuset Foundation (Stiftelsen Frimurare Barnhuset i Stockholm) (Sweden) |
| Funder | Childrens Hospital Karolinska University Hospital Huddinge Stockholm (Sweden) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective double-blind randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitrous oxide, midazolam |
| Primary outcome measure(s) |
1. Number of attempts that were required for double venous cannulation (number), 15 minutes after procedure |
| Key secondary outcome measure(s) |
1. Pain (Numeric Rating Scale [NRS] 0 - 10, where 0 = no pain and 10 = worst pain), evaluation by parent 15 minutes after procedure |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
14186
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
