Valutazione del dexmedetomidine per ridurre il dolore durante lo screening della retinopatia della prematurità in neonati prematuri <30 settimane con combinazione

Enrollment and consent

after you agree to join the study, a member of the research team will obtain your written consent and record basic information such as your birth weight and gestational age.

Baseline assessment

the team will measure your current weight, check vital signs and note any existing medical conditions. this information is needed to calculate the correct dose of the study medication.

Randomisation

you will be assigned, by a computer program, to receive either dexmedetomidine or a placebo solution. the assignment is unknown to the staff who care for you.

Pre‑procedure intranasal dose

if you are in the dexmedetomidine group, a dose of 2 µg per kilogram of body weight will be prepared from a 100 µg/ml solution and given as a small spray into each nostril. the total volume is calculated from your weight.

if you are in the placebo group, 0.3 ml of a 0.9 % sodium chloride (salt) solution will be given in the same way.

Waiting period

after the intranasal spray, you will be observed for about ten minutes to allow the medication to take effect before any eye treatment is started.

Administration of eye drops

three eye‑drop solutions are applied to each eye in the following order:

oxibuprokain – 1.2 mg (one drop) to provide local anaesthesia.

metaoxedrin – 150 µg (one drop) to dilate the pupil.

cyclopentolat – 150 µg (one drop) to keep the pupil dilated during the exam.

First eye examination (exam i)

the ophthalmologist inserts a small speculum to examine the retina. during the first 30 seconds after insertion, the team records the pain score using the Premature Infant Pain Profile‑Revised (PIPP‑R) scale.

Speculum removal and second pain assessment

after the examination, the speculum is removed and a second PIPP‑R pain score is recorded.

Vital‑sign monitoring

for the remainder of the procedure and for a short period afterward, heart rate, respiratory rate, oxygen saturation and any need for supplemental oxygen are monitored and documented.

Second eye examination (exam ii)

the same sequence of eye‑drop administration, speculum insertion, pain‑score recording and vital‑sign monitoring is repeated for the other eye.

Completion of the screening session

after both eyes have been examined, all observations are entered into the study database. no further study medication is given for that session.