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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00250692
First received: November 7, 2005
Last updated: November 28, 2005
Last verified: November 2005
History of Changes
  Purpose

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:

MedlinePlus related topics: Gas
U.S. FDA Resources

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

Primary Outcome Measures:
  • NIPS scale
  • salivary cortisol level

Estimated Enrollment: 52
  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Criteria

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

Locations
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
Investigators
Principal Investigator: Samuel Wald, MD UCLA Department of Anesthesiology
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013