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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-31

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.

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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

Conditions

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Preterm Newborns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Laser stimulation

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)

Group Type EXPERIMENTAL

Laser stimulation

Intervention Type DEVICE

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)

fake 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

Group Type PLACEBO_COMPARATOR

Fake laser stimulation

Intervention Type 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

Interventions

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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)

Intervention Type DEVICE

Fake 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

Intervention Type DEVICE

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)