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

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. Identifier: NCT00623220
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):
Nabeel Ali, McGill University Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Retinopathy of Prematurity Other: N2O Other: oxygen Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: A
O2 and N2O
Other: N2O
Other Name: equimolar oxygen and nitrous oxide

Active Comparator: B
O2 only
Other: oxygen

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00623220

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Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Nabeel Ali

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nabeel Ali, Doctor, McGill University Health Center Identifier: NCT00623220     History of Changes
Other Study ID Numbers: 07-008-PED
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents