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

Preterm Newborns Clinical Trial

— ELAPPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147717
• Other study ID #: P 130602
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: July 24, 2017
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Premature Birth
• Preterm Newborns

Intervention

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)
• 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

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Behavioral pain scale (DAN scale and EDIN scale)	Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)	48hours postoperative
Secondary	Consumption of morphine	Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative	48 hours postoperative
Secondary	Measurement of FIO2	Measurement of FIO2, mode of mechanical ventilation after surgery	48 hours postoperative