Clinical trial • Not applicable • Other

CLONIDINE HYDROCHLORIDE for Procedural pain during eye examination for retinopathy of prematurity (premature infants)

Not applicable trial of CLONIDINE HYDROCHLORIDE for Procedural pain during eye examination for retinopathy of prematurity (premature infants).

Overview

Trial Therapeutic Area: Other
Trial Disease: Procedural pain during eye examination for retinopathy of prematurity (premature infants)
Trial Stage: Not applicable
Drug Modality: Small molecule
Paediatric Trial: Yes

Not applicable trial across 2 sites in Sweden.

Recruits 50 paediatric patients.

Vulnerable Population: Vulnerable population: premature infants. Informed consent must be provided by the infant's guardian(s) (written consent). No assent process for children is described.

{"criterion_text":"- The infant is admitted to the study clinic\n- The infants guardian/s has/have given their written consent to the child's participation in the study\n- The infant is born before gestation week 30"}

{"criterion_text":"- Children who has received beta blockers, pain reliever or sedating drug within 24 hours of eye examination.\n- Previously documented kidney failure\n- Does not have a gastric tube\n- Neurologically affected\n- Known cardiac arrhythmia\n- Circulatory instability (defined as mean arterial pressure lower than the child's gestational age)"}

{"endpoint_text":"- PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.","definition_or_measurement_approach":"PIPP-R score measured within 30 seconds after initiation of the eye examination (when eye is held open/hooks in place) as specified per site (Uppsala/Örebro)."}

{"endpoint_text":"- GSR: Area small peaks, area huge peaks, peaks per second och average rise time","definition_or_measurement_approach":"Galvanic Skin Response (GSR) measures: area of small peaks, area of large peaks, peaks per second, and average rise time as recorded during/after procedure."}
{"endpoint_text":"- Number of reported AEs, SAEs and SUSARS","definition_or_measurement_approach":"Safety reporting: count of adverse events (AEs), serious adverse events (SAEs), and SUSARs reported during the study."}
{"endpoint_text":"- A VAS scale of 0-10 cm, from very easy to examin (0) to very difficult to examin (10)","definition_or_measurement_approach":"Visual Analog Scale (0-10 cm) rating ease/difficulty of examination, where 0 = very easy to examine and 10 = very difficult to examine."}

Planned Sample Size: 50
Recruitment Window Months: 56
Consent Approach: Written informed consent is obtained from the infant's guardian(s). A subject information and informed consent form document is listed. No details on assent or specific languages provided.

Investigational Product Name: CLONIDINE
Active Substance: CLONIDINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketed product (IMP is a marketed product already used in medical practice)
Maximum Dose: 4 (doseUom: mg/ml as stated in record)

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