Preterm Newborns
Conditions
Keywords
preterm newborns, Transfontanellar ultrafast doppler, Acupuncture, perioperative pain, surgery of the ductus arteriosus
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
Interventions
DEVICELaser 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)
DEVICEFake 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed