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A Study to Test the Pain-relieving Effect of Laughing Gas in Infants

Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00250692
Enrollment
0
Registered
2005-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2017-02-17

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

Conditions

Analgesic Affect

Brief summary

Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).

Interventions

DRUGNitrous Oxide

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 3 Months

Inclusion criteria

\- Full-term babies up to three months old scheduled for heel stick blood draw.

Exclusion criteria

* preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2\>40%), anemia, bone marrow suppression, or cardiac defect

Design outcomes

Primary

MeasureTime frame
NIPS scale
salivary cortisol level

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026