Acupuncture for Pain During Injection of Local Anaesthetic

Not Applicable

Completed

• Conditions: Distress; Satisfaction; Pain
• Interventions: Other: Acupuncture & acupressure

• Registration Number: NCT02197546
• Lead Sponsor: University Medicine Greifswald

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-06
• Study Completion: 2011-11
• Status Verified: 2014-07
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Last Update Submitted: 2014-07-21
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
acupuncture plus local anesthesia	Acupuncture & acupressure	Bilateral acupuncture with 1.5 mm long indwelling fixed needles

Primary Outcome Measures

Name	Time	Method
pain intensity	3 time points during one day of investigation

Secondary Outcome Measures

Name	Time	Method
pain intensity assessed by the parents and by physicians	4 time points during one day of investigation

Trial Locations

Locations (1)

University Medicine of Greifswald; 🇩🇪 Greifswald, Germany