Hôpital Robert Debré
Paris, 75019, France
Completed
NCT Number: NCT03757871
Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
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.
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Notify MeKey information
Conditions
Age range
23 week–31 week
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Laser stimulation
Devicean acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
Primary outcomes
-
score at PIPP (premature infant pain profile) ≥ 10
Time frame: 24 hours
Measurement of pain or discomfort defined by a PIPP score ≥ 10
Secondary outcomes
-
pain and discomfort
Time frame: 24 hours
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
-
heart rate variability
Time frame: 24 hours
assessment of heart rate variability (NIPE score)
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Acronym: ELAROP
Important dates
- Study start
- 2019
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Nov 29, 2018
- Registry last updated
- Apr 29, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.