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Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.
management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. Acupuncture has shown its analgesic efficacy in numerous studies in children and adults. Acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents
Main objective:
Assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ETS) after surgery ductus arteriosus in preterm infants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser stimulation | Experimental | Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment. This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery) |
|
| fake laser stimulation | Placebo Comparator | newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser stimulation | Device | Infants will be divided in 2 groups:
This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral pain scale (COMFORT scale) | Behavioral pain scale (COMFORT scale) studied at a painful procedure (endotracheal suctioning, ETS) with a regular assessment in perioperative. All the ETS will videotaped with a color digital camera by the research assistant. | 48 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral pain scale (DAN scale and EDIN scale) | Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale) | 48hours postoperative |
| Consumption of morphine | Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biran Valérie, PHD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Robert Debré | Paris | 75019 | France |
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| Fake laser stimulation | Device | newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage |
|
| 48 hours postoperative |
| Measurement of FIO2 | Measurement of FIO2, mode of mechanical ventilation after surgery | 48 hours postoperative |