Condition category
Surgery
Date applied
28/11/2008
Date assigned
16/01/2009
Last edited
24/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claude Marcus

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

Is nitrous oxide treatment improving patient care in the out-patient paediatric departments compared to midazolam?

Ethics approval

Ethical Committee of South Stockholm gave approval on the 14th January 2005 (ref: 050114)

Study design

Prospective double-blind randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Nitrous oxide, midazolam

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Children (aged 5 - 18 years, either gender) with well known difficulties to establish intravenous access.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. No ability to collaborate
2. Mental disturbance
3. Not fluent in Swedish

Recruitment start date

01/04/2005

Recruitment end date

30/12/2008

Locations

Countries of recruitment

Sweden

Trial participating centre

Division of Pediatrics, CLINTEC
Stockholm
14186
Sweden

Sponsor information

Organisation

Frimurare Barnhuset Foundation (Stiftelsen Frimurare Barnhuset i Stockholm) (Sweden)

Sponsor details

Nybrokajen 7
Stockholm
111 48
Sweden
sfbs@frimurarorden.se

Sponsor type

Research organisation

Website

http://www.frimurarorden.se/

Funders

Funder type

Hospital/treatment centre

Funder name

Childrens Hospital Karolinska University Hospital Huddinge Stockholm (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21536947
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22677811

Publication citations

  1. Results

    Ekbom K, Kalman S, Jakobsson J, Marcus C, Efficient intravenous access without distress: a double-blind randomized study of midazolam and nitrous oxide in children and adolescents., Arch Pediatr Adolesc Med, 2011, 165, 9, 785-791, doi: 10.1001/archpediatrics.2011.56.

  2. Results

    Ekbom K, Kalman S, Jakobsson J, Marcus C, Effects of midazolam and nitrous oxide on endocrine and metabolic measurements in children., Horm Res Paediatr, 2012, 77, 5, 309-319, doi: 10.1159/000337536.

Additional files

Editorial Notes