Laser Acupuncture for Pain Prevention in Neonates

University Children Hospital Homburg

Status: Completed

Conditions: Pain

Treatments: Procedure: placebo laser acupuncture; Procedure: active laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00528125

SG-07-H-02

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Active laser acupuncture

Treatment:

Procedure: active laser acupuncture

B

Placebo Comparator group

Description:

placebo laser acupuncture

Treatment:

Procedure: placebo laser acupuncture