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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Newborns
• Intervention / Treatment: Device: Laser stimulation; Device: Fake laser stimulation

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Robert Debré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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)
Placebo Comparator: 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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Biran Valerie, PHD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Acupuncture; preterm newborns; Transfontanellar ultrafast doppler; perioperative pain; surgery of the ductus arteriosus
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Defects, Congenital; Cardiovascular Abnormalities; Premature Birth; Ductus Arteriosus, Patent
• Other Study ID Numbers: P 130602