Acupuncture for Pain During Injection of Local Anaesthetic

Pain Clinical Trial

— AcuDent  

Official title:

Acupuncture Reduces Pain and Autonomous Distress During Injection of Local Anaesthetic in Children - a Randomised Crossover Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197546
• Other study ID #: BB 57/10
• Secondary ID: BB 57/10
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: July 21, 2014
• Start date: July 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2014
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and distress in children receiving an injection of a local anaesthetic (LA). Children scheduled for dental treatment using local anesthesia as a standard treatment, received bilateral acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the patients stimulated the needles by massage. Two different treatment regimes were compared: a standardized LA injection given 5 minutes after acupuncture, and an LA injection without acupuncture. The order of treatment was randomised, with the two treatments performed on different days. Pain intensity during LA injection, assessed by the patient with the Verbal Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction with the received therapy were also recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• children with an American Society of Anesthesiologists (ASA) physical status of I or II

• scheduled for at least two dental treatments for caries requiring local anaesthesia

Exclusion Criteria:

• history of analgesic medication, psychiatric disease, or local or systemic infection

• necessity to change their treatment schedule

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distress
• Pain
• Satisfaction

Intervention

Other:
• Acupuncture & acupressure
Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate		5 time points during one days of investigation	No
Primary	pain intensity		3 time points during one day of investigation	No
Secondary	pain intensity assessed by the parents and by physicians		4 time points during one day of investigation	No