Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067958

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity Dexmedetomidine	Drug: Dexmedetomidine Drug: Saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This will be a crossover, prospective randomized controlled trial. Block randomization with stratification based on gestational age (cutoff of 28+0) will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.This will be a crossover, prospective randomized controlled trial. Block randomization with stratification based on gestational age (cutoff of 28+0) will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.

Masking:

Quadruple (Participant, Care Provider, 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

Primary Purpose:

Treatment

Official Title:

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: A Crossover Randomized Controlled Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination	Drug: Dexmedetomidine 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.
Placebo Comparator: Placebo Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination	Drug: Saline 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.

Arm

Intervention/Treatment

Active Comparator: Dexmedetomidine

Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination

Drug: Dexmedetomidine

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.

Placebo Comparator: Placebo

Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination

Drug: Saline

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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
Heart rate [Assessed every hour from time 0 until 5 hours after the examination]
The average heart rate of the infant
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