Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera (ELAROP)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Laser Stimulation

Treatments: Device: Laser stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03757871

P171005J

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 23 to 31 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
• Premature birth weights < 1250g with a 1st FO for ROP screening;
• Informed consent of the holder(s) of parental authority;
• Child benefiting from a social security system

Exclusion criteria

• Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
• Known chromosomal abnormality

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Laser Stimulation

Experimental group

Description:

laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.

Treatment:

Device: Laser stimulation

Placebo

Placebo Comparator group

Description:

The placebo group will have an application of the pen according to the same extinguished laser criteria.

Treatment:

Device: Laser stimulation