临床试验/2023-507975-23-01

2023-507975-23-01招募中2 期

Pain Relief at Screening for Retinopathy of Prematurity - The PROPER study

St. Olavs Hospital HF2 个研究点分布在 1 个国家目标入组 33 人开始时间: 2026年9月1日最近更新: 2026年6月22日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: St. Olavs Hospital HF
入组人数: 33
试验地点: 2
主要终点: Pain score assessed with the Premature Infant Pain Profile-Revised (PIPP-R) during the 30 seconds following speculum insertion (Eye exam I and II)

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine whether intranasal dexmedetomidine (DEX) 2 µg/kg, as an adjunct to standard care, provides lower procedural pain scores during ROP screening compared to placebo in preterm infants born at GA <30 weeks.

入排标准

年龄范围: 0 years 至 17 years（0-17 Years）
接受健康志愿者: 否

入选标准

•Preterm infants with GA <30 weeks who receive routine ROP screening and signed parental informed consent

排除标准

•Received pharmacological sedation/analgesia (except sucrose) within 24 hours before the eye examination
•Severe intraventricular hemorrhage (grade 3-4)
•Cerebral malformations
•Congenital heart disease
•Mechanical ventilation or vasopressor at the time of the examination
•Nasal anatomical abnormalities that may interfere with intranasal drug administration or absorption
•Hypersensitivity to dexmedetomidine or to any of its excipients
•Uncontrolled hypotension
•Acute cerebrovascular conditions other than those already listed
•Clinically significant pre-existing bradycardia not attributable to apnea or other reversible causes
•Severe hepatic impairment

结局指标

主要结局

Pain score assessed with the Premature Infant Pain Profile-Revised (PIPP-R) during the 30 seconds following speculum insertion (Eye exam I and II)

次要结局

1.HR, RR, oxygen saturation, and supplemental oxygen requirement 2. Number of cardiorespiratory events. 3. PIPP-R score following speculum removal. 4. Change in respiratory support mode. 5. Duration of first cry episode. 6. Total sleep duration. 7. Number of vomiting episodes. 8. Cerebral blood flow velocities. Exploratory endp: 1.NeoDoppler blood flow patterns. 2. Cerebral Doppler velocities and pain score. 3. Ophthalmologist VAS score

研究者

发起方

St. Olavs Hospital HF

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Laila Kristoffersen

Scientific

St. Olavs Hospital HF

研究点 (2)

Loading locations...

相似试验

尚未招募

不适用

Intranasal dexmedetomidine as an adjunct to standard pain control in retinopathy of prematurity screening in neonates

CTRI/2024/12/077659Animesh Sahu102

尚未招募

2 期

"Effect of a nasal sedative named dexmedetomidine on eye nerve pressure in adults undergoing throat surgery with a viewing scope"

CTRI/2025/07/092104AIIMS, New Delhi60

尚未招募

4 期

Early Dexmedetomidine and Sympathetic Regulation in SepsisSepsisSeptic Shock

NCT07470775Sichuan Academy of Medical Sciences168

尚未招募

Unknown

A Study to See if Adding Dexmedetomidine to Local Anesthesia Improves Pain Control in Minor Oral and Jaw Surgeries

CTRI/2026/03/105173GUNTUBOINA SREE VARSHA34

尚未招募

不适用

Comparing Two Different Amounts of a Drug (Dexmedetomidine) Added to a Numbing Medicine (Bupivacaine) for Better Pain Relief During Arm Surgery Using an Ultrasound-Guided Nerve Block

CTRI/2025/10/095958School of medical sciences and research Sharda hospital Sharda university99