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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Preterm Newborns

Treatments: Device: Fake laser stimulation; Device: Laser stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02147717

P 130602

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Laser stimulation

Experimental group

Description:

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)

Treatment:

Device: Laser stimulation

fake laser stimulation

Placebo Comparator group

Description:

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

Treatment:

Device: Fake laser stimulation