Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation

Conditions
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Preterm Newborns

Intervention / Treatment
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* Device: Laser stimulation
* Device: Fake laser stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infant born between 24 +0 and 32 +6 j GA Ductus arteriosus surgery scheduled in Robert Debré hospital Informed consent of the holders of the exercise of parental authority Child beneficiary of a social security scheme (excluding AME) Exclusion Criteria: Obvious underlying disease (genetic, metabolic)

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser stimulation<br>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<br>* 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)<br>|
| Placebo Comparator: fake laser stimulation<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 48 hours postoperative | 
| Measurement of FIO2 | Measurement of FIO2, mode of mechanical ventilation after surgery | 48 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative pain, surgery of the ductus arteriosus, preterm newborns, Transfontanellar ultrafast doppler, Acupuncture