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

NCT00623220 | Completed Phase 3

• 1 other identifier: 07-008-PED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (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

  PIPP score before, during and after eye exam

Secondary Outcomes (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.

  during 48 hours

Study Arms (2)

A

EXPERIMENTAL

O2 and N2O

Other: N2O

B

ACTIVE COMPARATOR

O2 only

Other: oxygen

Interventions

N2O OTHER

EMONO

Also known as: equimolar oxygen and nitrous oxide

A

oxygen OTHER

oxygen

B

Eligibility Criteria

• Age: 32 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Nabeel Ali: lead

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• Mandel R, Ali N, Chen J, Galic IJ, Levesque L. Nitrous oxide analgesia during retinopathy screening: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2012 Mar;97(2):F83-7. doi: 10.1136/adc.2011.210740. Epub 2011 Aug 10.

  PMID: 21835837 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Pain; Premature Birth

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

CA (1)