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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabeel Ali, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00623220
First received: February 13, 2008
Last updated: October 28, 2013
Last verified: October 2013
  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:


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 ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623220

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Nabeel Ali
  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: Nabeel Ali, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00623220     History of Changes
Other Study ID Numbers: 07-008-PED
Study First Received: February 13, 2008
Last Updated: October 28, 2013
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, Newborn, Diseases
Infant, Premature, Diseases
Nitrous Oxide
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014