Laser Acupuncture for Pain Prevention in Neonates

University Children Hospital Homburg50 enrolled

Overview

Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that early pain experience can have a tremendous impact on the pain memory. We want to investigate if a simple, fast method, that is nearly devoid of side effects can lead to a significant alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture in neonates are lacking so far. Our hypothesis is that neonates in the active laser group experience less pain than those in the placebo group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

active laser acupuncturePROCEDURE

low level laser acupuncture, 830 nm, 30 mW, 0,3 J per acupoint, 2 points per neonate (Hegu and Shen Men). Overall 30 seconds of treatment

placebo laser acupuncturePROCEDURE

placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication Exclusion Criteria: * Older than 28 days

Locations (1)

University Children Hospital Homburg

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

The Pain score Premature Infant Pain Profile (PIPP), according to video analysis

The Premature Infant Pain Profile (PIPP Score) is a reliable instrument to measure acute pain in neonates and it includes objective vital parameters and is not only a third-party observation. A total of seven indicators are measured: Three behavioural indicators (facial actions: eye squeeze, brow bulge and nasolabial furrow), two physiological indicators (heart rate and oxygen saturation), and two contextual indicators (gestational age and behavioral state). A scoring of 0, 1, 2 or 3 points is used for each of the seven indicators. All indicators are summed up to a total score. Depending on the gestational age, the possible total score ranges from 18 to 21.

Time frame: 5 minutes from the heel prick

Secondary Outcomes

Cry Time

in seconds (according to the Audio track of the video analysis)

Time frame: right after after heel prick up to 5 minutes

Data from ClinicalTrials.gov

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