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

NCT ID: NCT03757871

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2020-03-01

Brief 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.

Detailed 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.

Conditions

Laser Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Laser Stimulation

laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.

Group Type: EXPERIMENTAL

Laser stimulation

Intervention Type: DEVICE

an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.

Placebo

The placebo group will have an application of the pen according to the same extinguished laser criteria.

Group Type: PLACEBO_COMPARATOR

Laser stimulation

Intervention Type: DEVICE

an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.

Interventions

Laser stimulation

an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farnoux Caroline, PHD

Role: PRINCIPAL_INVESTIGATOR

APHP

Biran Valerie, PHD

Role: STUDY_CHAIR

APHP

Locations

Hôpital Robert Debré

Paris, , France

Countries

France

Other Identifiers

P171005J

Identifier Type: -

Identifier Source: org_study_id