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

Phase 3

Withdrawn

• Conditions: Analgesic Affect

• Registration Number: NCT00250692
• Lead Sponsor: University of California, Los Angeles

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-07
• Study First Submitted QC: 2005-11-07
• Study First Posted: 2005-11-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
NIPS scale
salivary cortisol level

Trial Locations

Locations (1)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States