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

Sponsored by:	McGill University Health Center
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00623220

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 III

MedlinePlus related topics: Premature Babies Retinal Disorders

Drug Information available for: Nitrous oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
A: Experimental O2 and N2O	Other: N2O EMONO
B: Active Comparator O2 only	Other: oxygen oxygen

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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

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

Keywords provided by McGill University Health Center:

pain, retinopathy of prematurity, infant, premature, eye exam, nitrous oxide

Study placed in the following topic categories:

Nitrous Oxide
Eye Diseases
Retinopathy of prematurity
Infant, Newborn, Diseases

Infant, Premature, Diseases
Retinopathy of Prematurity
Pain
Retinal Diseases

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009