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NCT Number: NCT02147717

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

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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Key information

Conditions

Preterm Newborns

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Robert Debré

Paris, 75019, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laser stimulation

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

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

Primary outcomes

  1. Behavioral pain scale (COMFORT scale)

    Time frame: 48 hours post-operative

    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.

Secondary outcomes

  1. Behavioral pain scale (DAN scale and EDIN scale)

    Time frame: 48hours postoperative

    Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)

  2. Consumption of morphine

    Time frame: 48 hours postoperative

    Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative

  3. Measurement of FIO2

    Time frame: 48 hours postoperative

    Measurement of FIO2, mode of mechanical ventilation after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ELAPPS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 28, 2014
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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