Acupuncture for Pain During Injection of Local Anaesthetic (AcuDent)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Distress; Satisfaction
• Intervention / Treatment: Other: Acupuncture & acupressure

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • University Medicine of Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: acupuncture plus local anesthesia; Bilateral acupuncture with 1.5 mm long indwelling fixed needles	Other: Acupuncture & acupressure; Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents
No Intervention: Local anesthesia alone; Standard therapy - local anesthesia alone without acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain intensity	3 time points during one day of investigation

Secondary Outcome Measures

Outcome Measure	Time Frame
pain intensity assessed by the parents and by physicians	4 time points during one day of investigation

Other Outcome Measures

Outcome Measure	Time Frame
heart rate	5 time points during one days of investigation

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Study Chair: Christian Splieth, MD, PhD, University Medicine of Greifswald

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: acupuncture; local anesthesia; Injection pain
• Other Study ID Numbers: BB 57/10 (Other Identifier: BB 57/10)