Acupuncture for Pain During Injection of Local Anaesthetic

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Distress, Satisfaction

Intervention / Treatment
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* Other: Acupuncture & acupressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injection pain, local anesthesia, acupuncture