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Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-Term Infant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00623220
First received: February 13, 2008
Last updated: October 8, 2008
Last verified: October 2008
History of Changes
  Purpose

The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia).

The investigators also aim to show that EMONO can be used safely in preterm neonates undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or desaturation in the 24 hours following the exam. Finally, the investigators aim to show that EMONO will keep the infant calm, and make retinal examination easier and less traumatic.


Condition Intervention Phase
Retinopathy of Prematurity
 Other: N2O
Other: oxygen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Effectiveness of Inhaled Nitrous Oxide for Pain Relief During ROP Screening Exam in the Pre-Term Infant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score [ Time Frame: PIPP score before, during and after eye exam ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart and respiratory rate will be monitored using one of our NICU integrated monitors. Continuous pulse oximetry will be performed with a Masimo Radical pulse oximeter. [ Time Frame: during 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
O2 and N2O
 Other: N2O
EMONO
Other Name: equimolar oxygen and nitrous oxide
Active Comparator: B
O2 only
 Other: oxygen
oxygen
Other Name: oxygen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   32 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requiring retinal exam for ROP screening
  • Clinically stable
  • At least 30 0/7 weeks of corrected gestational age at the time of study
  • Not on mechanical ventilation or CPAP at the time of study
  • Requiring an inspired concentration of oxygen less than 50%

Exclusion Criteria:

  • - Craniofacial malformations
  • Cyanotic cardiac disease
  • Hemodynamically significant cardiac lesions
  • Known pneumothorax or pneumomediastinum
  • Congenital pulmonary malformations
  • Neuromuscular disease
  • Receiving opiates, benzodiazepines or barbiturates at the time of study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623220

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Romain Mandel, MD, MSc     (001) 514.934.1934 ext 34 876     romain.mandel@mcgill.ca    
Contact: Ali Nabeel, MD     (001) 514.934.1934 ext 34 876     nabeel.ali@mcgill.ca    
Principal Investigator: Romain Mandel, MD, MSc            
Sponsors and Collaborators
McGill University Health Center
  More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mandel/MD, MSc, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00623220     History of Changes
Other Study ID Numbers: PED-07-008
Study First Received: February 13, 2008
Last Updated: October 8, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
pain, retinopathy of prematurity, infant, premature, eye exam, nitrous oxide

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
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 June 18, 2013