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

Primary Purpose

Preterm Newborns

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laser stimulation
Fake laser stimulation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Newborns focused on measuring preterm newborns, Transfontanellar ultrafast doppler, Acupuncture, perioperative pain, surgery of the ductus arteriosus

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesDoes not accept 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)

Sites / Locations

  • Hôpital Robert Debré

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser stimulation

fake laser stimulation

Arm 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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Behavioral pain scale (DAN scale and EDIN scale)
Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)
Consumption of morphine
Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative
Measurement of FIO2
Measurement of FIO2, mode of mechanical ventilation after surgery

Full Information

First Posted
May 19, 2014
Last Updated
July 24, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02147717
Brief Title
Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
Acronym
ELAPPS
Official Title
Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Newborns
Keywords
preterm newborns, Transfontanellar ultrafast doppler, Acupuncture, perioperative pain, surgery of the ductus arteriosus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser stimulation
Arm Type
Experimental
Arm 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)
Arm Title
fake laser stimulation
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Laser stimulation
Intervention Description
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
Intervention Name(s)
Fake laser stimulation
Intervention 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
Primary Outcome Measure Information:
Title
Behavioral pain scale (COMFORT scale)
Description
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.
Time Frame
48 hours post-operative
Secondary Outcome Measure Information:
Title
Behavioral pain scale (DAN scale and EDIN scale)
Description
Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)
Time Frame
48hours postoperative
Title
Consumption of morphine
Description
Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative
Time Frame
48 hours postoperative
Title
Measurement of FIO2
Description
Measurement of FIO2, mode of mechanical ventilation after surgery
Time Frame
48 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biran Valérie, PHD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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