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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00250692
Collaborator
(none)
0
Enrollment
1
Location

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitrous Oxide
 Phase 3

Study Design

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

Outcome Measures

Primary Outcome Measures

  1. NIPS scale []

  2. salivary cortisol level []

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Minute to 3 Months
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00250692
Other Study ID Numbers:
  • 05-04-029-01
First Posted:
Nov 8, 2005
Last Update Posted:
Feb 17, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Nitrous Oxide

Study Results

No Results Posted as of Feb 17, 2017