A Randomized Controlled Trial on the Effectiveness of Inhaled Nitrous Oxide for Pain Relief During ROP Screening Exam in the Pre-term Infant
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score
Study Overview
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.
Detailed Description
Methods
- Study population:
Eligible patients will be healthy preterm infants born at 30 0/7 or less than weeks of gestation, or weigh less than 1500 grams at birth, requiring retinopathy of prematurity (ROP) screening examination as indicated by AAP guidelines. 2. Recruitment:
Patients will be recruited at the Royal Victoria Hospital Neonatal Intensive Care Unit. Subjects will be enrolled after written informed consent has been obtained from a parent or legal guardian. Although a single patient may require multiple retinal exams, each infant will only be studied once under this protocol. Total number of eligible patients, as well as consent refusals will be recorded during the study period.
The study will be conducted in two phases. A pilot phase, comprising 9 infants, will be performed first. The purpose of the pilot study is to establish the safety of EMONO for this indication, evaluate the technical feasibility of administering EMONO in the NICU setting, and determining the optimal nasal interface for inhalation. All subjects during the pilot phase will receive EMONO.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 32 Weeks to — (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Nabeel Ali
Doctor
McGill University Health Centre/Research Institute of the McGill University Health Centre