Laser Stimulation
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICELaser stimulation
an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 31 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| score at PIPP (premature infant pain profile) ≥ 10 | 24 hours | Measurement of pain or discomfort defined by a PIPP score ≥ 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain and discomfort | 24 hours | Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score \< 3 |
| heart rate variability | 24 hours | assessment of heart rate variability (NIPE score) |
Countries
France
Outcome results
None listed