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Completed

NCT Number: NCT02197546

Acupuncture for Pain During Injection of Local Anaesthetic

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.

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Key information

Conditions

Pain Behavior Distress Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine of Greifswald

Greifswald, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture & acupressure

Other

Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents

Primary outcomes

  1. pain intensity

    Time frame: 3 time points during one day of investigation

Secondary outcomes

  1. pain intensity assessed by the parents and by physicians

    Time frame: 4 time points during one day of investigation

Other outcomes

  1. heart rate

    Time frame: 5 time points during one days of investigation

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: AcuDent

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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