An interventional study of Laser stimulation and Fake laser stimulation in Preterm Newborns, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 40 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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)
Device: Laser stimulation
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
Device: Fake laser stimulation
Infants will be divided in 2 groups: * Placebo group: Placebo (fake laser stimulation) plus opioid treatment before ETS * Experimental group: 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)
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
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.
Time frame: 48 hours post-operative
Behavioral pain scale (DAN scale and EDIN scale)
Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)
Time frame: 48hours postoperative
Consumption of morphine
Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative
Time frame: 48 hours postoperative
Measurement of FIO2
Measurement of FIO2, mode of mechanical ventilation after surgery
Time frame: 48 hours postoperative
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris