Dexmedetomidine, Retinopathy of Prematurity
Conditions
Keywords
Retinopathy of Prematurity, Dexmedetomidine, Pain, Analgesia, Premature Infant Pain Profile - Revised
Brief summary
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed retinopathy of prematurity. While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations. The main questions it aims to answer are: * Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%). * Does dexmedetomidine cause more adverse effects than placebo. In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.
Interventions
DRUGDexmedetomidine
Intranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
DRUGSaline
Intranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The units pharmacologist will be responsible for patient assignment and preparation of the medication / placebo syringes but will remain blinded to the other aspects of the trial. The patient's nurse, attending physician, ophthalmologist, investigator and outcome assessor will remain blinded to the patient allocation
Intervention model description
This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.
Eligibility
Sex/Gender
ALL
Age
4 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams * Informed consent signed by one of the parents
Exclusion criteria
* Invasive ventilation at the time of the eye assessment * Multiple congenital anomalies * Chromosomal / genetic anomalies * Infant received a sedative drug in last 5 days * Eye examination for reasons other than retinopathy of prematurity screening * Attending physician deemed the patient not stable enough
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Premature Infant Pain Profile: Revised, at peak | PIPP-R score will be assessed 60 seconds after the insertion of the retractor | The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort. Every participant will be assessed using video recordings which will start 5 minutes before the administration of oral sucrose 24% and will continue until 5 minutes after the removal of the eyelid retractor. The primary outcome will be the PIPP-R score one minute after the insertion of the retractor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Premature Infant Pain Profile: Revised, at completion | 2 minutes after the removal the retractors | The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort. For this secondary outcome, PIPP-R score 2 minutes after the after the removal the retractors will be assessed. |
| Apnea | From time 0 until 5 hours after the examination | Number of apneas or desaturations \< 90% |
| Bradycardia | From time 0 until 5 hours after the examination | Number of bradycardias, defined as a drop of 20% from baseline heart rate |
| The Premature Infant Pain Profile: Revised, 5 minutes | 5 minutes after the insertion of the retractor | The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort. For this secondary outcome, PIPP-R score 5 minutes after the insertion of the retractor will be assessed. |
| Duration of examination | Up to 30 minutes | The time between the insertion and the removal of the retractor |
| Percent of crying time | The duration of the video recording (up to 1 hour) | The percent of time in which the participant cried during the video recording |
| Heart rate | Assessed every hour from time 0 until 5 hours after the examination | The average heart rate of the infant |
Countries
Israel
Contacts
Primary ContactSagee Nissimov, MD
Backup ContactIris Morag, MD
Outcome results
None listed