Laser Stimulation Clinical Trial
Official title:
Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Pain management in premature infants is essential because they are exposed to repeated minor
painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown
its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast,
side-effect-free method, but no study exists on the contribution of acupuncture in the
management of pain caused by the examination of the fundus in addition to conventional
therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently
effective.
Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort
of premature newborns when examining the fundus with a digital camera.
Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes. ;