Laser Acupuncture for Pain Prevention in Neonates

Pain Clinical Trial

Official title:

Laser Acupuncture for Pain Prevention in Neonates Undergoing Heel Prick. A Prospective, Randomized, Double-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528125
• Other study ID #: SG-07-H-02
• Status: Completed
• Phase: N/A
• First received: September 11, 2007
• Last updated: March 27, 2018
• Start date: September 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: University Children Hospital Homburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Germany	University Children Hospital Homburg	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Children Hospital Homburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes from the heel prick
Secondary	Cry Time	in seconds (according to the Audio track of the video analysis)	right after after heel prick up to 5 minutes