Acupuncture for Pain During Injection of Local Anaesthetic (AcuDent)

University Medicine Greifswald

Status: Completed

Conditions: Satisfaction; Distress; Pain

Treatments: Other: Acupuncture & acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02197546

BB 57/10 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

acupuncture plus local anesthesia

Other group

Description:

Bilateral acupuncture with 1.5 mm long indwelling fixed needles

Treatment:

Other: Acupuncture & acupressure

Local anesthesia alone

No Intervention group

Description:

Standard therapy - local anesthesia alone without acupuncture