Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera

Laser Stimulation Clinical Trial

— ELAROP  

Official title:

Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757871
• Other study ID #: P171005J
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.

Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

Description:

Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 31 Weeks

Eligibility

Inclusion Criteria:

• Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;

• Premature birth weights < 1250g with a 1st FO for ROP screening;

• Informed consent of the holder(s) of parental authority;

• Child benefiting from a social security system

Exclusion Criteria:

• Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.

• Known chromosomal abnormality

Related Conditions & MeSH terms

• Laser Stimulation
• Retinopathy of Prematurity

Intervention

Device:
• Laser stimulation
an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.

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	score at PIPP (premature infant pain profile) = 10	Measurement of pain or discomfort defined by a PIPP score = 10	24 hours
Secondary	pain and discomfort	Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score < 3	24 hours
Secondary	heart rate variability	assessment of heart rate variability (NIPE score)	24 hours