AcuDent: Acupuncture for Pain During Injection of Local Anaesthetic

• Sponsor: University Medicine Greifswald (Other)
• Overall Status: Completed
• CT.gov ID: NCT02197546
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Distress; Satisfaction	Other: Acupuncture & acupressure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acupuncture Reduces Pain and Autonomous Distress During Injection of Local Anaesthetic in Children - a Randomised Crossover Investigation
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. pain intensity [3 time points during one day of investigation]

Secondary Outcome Measures

1. pain intensity assessed by the parents and by physicians [4 time points during one day of investigation]

Other Outcome Measures

1. heart rate [5 time points during one days of investigation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medicine of Greifswald	Greifswald		Germany	17475

Sponsors and Collaborators

• University Medicine Greifswald

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Medicine Greifswald
• ClinicalTrials.gov Identifier: NCT02197546
• Other Study ID Numbers: BB 57/10; BB 57/10
• First Posted: Jul 22, 2014
• Last Update Posted: Jul 22, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by University Medicine Greifswald: Injection pain; local anesthesia; acupuncture

Study Results

No Results Posted as of Jul 22, 2014