Acupuncture for Pain During Injection of Local Anaesthetic

NCT02197546 | Completed

• 1 other identifier: BB 57/10
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Distress; Satisfaction

Keywords

Injection pain; local anesthesia; acupuncture

Outcome Measures

Primary Outcomes (1)

• pain intensity

  3 time points during one day of investigation

Secondary Outcomes (1)

• pain intensity assessed by the parents and by physicians

  4 time points during one day of investigation

Other Outcomes (1)

• heart rate

  5 time points during one days of investigation

Study Arms (2)

acupuncture plus local anesthesia

OTHER

Bilateral acupuncture with 1.5 mm long indwelling fixed needles

Other: Acupuncture & acupressure

Local anesthesia alone

NO INTERVENTION

Standard therapy - local anesthesia alone without acupuncture

Interventions

Acupuncture & acupressure OTHER

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

acupuncture plus local anesthesia

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• history of analgesic medication, psychiatric disease, or local or systemic infection
• necessity to change their treatment schedule

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Pain; Personal Satisfaction

Interventions

Acupuncture Therapy; Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Officials

• Christian Splieth, MD, PhD

  University Medicine of Greifswald

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

DE (1)