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NCT Number: NCT06067958

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

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.

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Key information

Conditions

Retinopathy of Prematurity Agnosia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dexmedetomidine Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Retinal Diseases Signs and Symptoms

Age range

4 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assaf-Harofeh Medical Center

Be’er Ya‘aqov, Center, 7033001, Israel

Location status: Recruiting

Location contact

Iris Morag, MD

CONTACT

Sagee Nissimov, MD

CONTACT

[email protected]

97289779080

Sagee Nissimov, MD

CONTACT

Sigal Zmujack-Yehiam, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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.

Saline

Drug

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.

Primary outcomes

  1. The Premature Infant Pain Profile: Revised, at peak

    Time frame: 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 outcomes

  1. The Premature Infant Pain Profile: Revised, 5 minutes

    Time frame: 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.

  2. The Premature Infant Pain Profile: Revised, at completion

    Time frame: 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.

  3. Apnea

    Time frame: From time 0 until 5 hours after the examination

    Number of apneas or desaturations < 90%

  4. Bradycardia

    Time frame: From time 0 until 5 hours after the examination

    Number of bradycardias, defined as a drop of 20% from baseline heart rate

  5. Heart rate

    Time frame: Assessed every hour from time 0 until 5 hours after the examination

    The average heart rate of the infant

  6. Duration of examination

    Time frame: Up to 30 minutes

    The time between the insertion and the removal of the retractor

  7. Percent of crying time

    Time frame: The duration of the video recording (up to 1 hour)

    The percent of time in which the participant cried during the video recording

Study contacts

Contact information is provided by the study sponsor or research team.

Iris Morag, MD

CONTACT

[email protected]

97289778286

Sagee Nissimov, MD

CONTACT

[email protected]

97289779080

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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