Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

Phase 1

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: Sterile saline; Drug: Buprenorphine; Drug: lidocaine, epinephrine (Local anesthetic)

• Registration Number: NCT03268278
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-31
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered

Exclusion Criteria

• pregnancy, allergy to buprenorphine, allergy to local anesthetic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sterile saline and local anesthetic	lidocaine, epinephrine (Local anesthetic)	sterile saline (placebo) added to local anesthetic
buprenorphine and local anesthetic	lidocaine, epinephrine (Local anesthetic)	buprenorphine added to local anesthetic
sterile saline and local anesthetic	Sterile saline	sterile saline (placebo) added to local anesthetic
buprenorphine and local anesthetic	Buprenorphine	buprenorphine added to local anesthetic

Primary Outcome Measures

Name	Time	Method
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia	two years	The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States