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

This study has been withdrawn prior to enrollment.
(unknown - no record of study conduct in departmental archive)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250692
First Posted: November 8, 2005
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Los Angeles
  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
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

Enrollment: 0
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250692


Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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
First Submitted: November 7, 2005
First Posted: November 8, 2005
Last Update Posted: February 17, 2017
Last Verified: February 2017

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