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

NCT00250692 | Withdrawn Phase 3

• 1 other identifier: 05-04-029-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Analgesic Affect

Outcome Measures

Primary Outcomes (2)

• NIPS scale

• salivary cortisol level

Interventions

Nitrous Oxide DRUG

Eligibility Criteria

• Age: 1 Minute - 3 Months
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Samuel Wald, MD

  UCLA Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

US (1)