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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Stimulation | Experimental | laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point. |
|
| Placebo | Placebo Comparator | The placebo group will have an application of the pen according to the same extinguished laser criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser stimulation | Device | an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| score at PIPP (premature infant pain profile) ≥ 10 | Measurement of pain or discomfort defined by a PIPP score ≥ 10 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| pain and discomfort | 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 | 24 hours |
| heart rate variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farnoux Caroline, PHD | APHP | Principal Investigator |
| Biran Valerie, PHD | APHP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Robert Debré | Paris | 75019 | France |
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assessment of heart rate variability (NIPE score) |
| 24 hours |