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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2005 by University of California, Los Angeles
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
First received: November 7, 2005
Last updated: November 28, 2005
Last verified: November 2005
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).

Condition Intervention Phase
Analgesic Affect
Drug: Nitrous Oxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • NIPS scale
  • salivary cortisol level

Estimated Enrollment: 52

Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250692

United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Samuel Wald, MD    310-206-0085    swald@mednet.ucla.edu   
Principal Investigator: Samuel Wald, MD         
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Samuel Wald, MD UCLA Department of Anesthesiology
  More Information

ClinicalTrials.gov Identifier: NCT00250692     History of Changes
Other Study ID Numbers: 05-04-029-01 
Study First Received: November 7, 2005
Last Updated: November 28, 2005

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 23, 2017