Evaluation of nitrous oxide treatment given to children with procedural problems - a comparison with midazolam and the release of hormones

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33779750

Enrollment

Registered

2009-01-16

Start date

2005-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficulties establishing intravenous access Surgery Procedural difficulties

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026