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

Not Applicable

Completed

• Conditions: Preterm Newborns
• Interventions: Device: Laser stimulation; Device: Fake laser stimulation

• Registration Number: NCT02147717
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Status Verified: 2016-08
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser stimulation	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)
fake laser stimulation	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

Primary Outcome Measures

Name	Time	Method
Behavioral pain scale (COMFORT scale)	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 Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Robert Debré; 🇫🇷 Paris, France