Validation of analgesic effect of nitrous oxide in neonates and infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71821503

Enrollment

270

Registered

2004-09-30

Start date

2000-05-01

Completion date

Unknown

Last updated

2016-11-28

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

Conditions

Neonatal and infant analgesia Neonatal Diseases Analgesia

Interventions

Prospectively randomised, placebo-controlled, clinical trial. Patients randomised to: 1. Nitrous oxide 2. Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pre-term newborns (32 - 37 weeks), n = 90 2. Full-term newborns (38 - 42 weeks), n = 90 3. Infants (1 - 3 months), n = 90

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
1. Neonatal pain assessment tool (developed by Keeble and Twaddle [1995]) 2. Physiologic parameters: 2.1. Blood pressure 2.2. Heart rate 2.3. Respiratory rate 2.4. Oxygen saturation	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026