Laser Acupuncture for Pain Prevention in Neonates

NCT00528125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-03-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

active laser acupuncture

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

PROCEDURE

placebo laser acupuncture

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

Sponsors & Collaborators

  • University Children Hospital Homburg

    lead OTHER

Principal Investigators

  • Sven Gottschling, MD · University Children Hospital Homburg, Germany

  • Ludwig Gortner, MD, PhD · University Children Hospital Homburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528125 on ClinicalTrials.gov