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Efficacy of Buprenorphine on Postoperative Endodontic Analgesia (EBPEA)

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sterile saline
lidocaine, epinephrine (Local anesthetic)
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring analgesia, endodontic, postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

buprenorphine and local anesthetic

sterile saline and local anesthetic

Arm Description

buprenorphine added to local anesthetic

sterile saline (placebo) added to local anesthetic

Outcomes

Primary Outcome Measures

The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2017
Last Updated
April 19, 2019
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03268278
Brief Title
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
Acronym
EBPEA
Official Title
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Loss of interest
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
analgesia, endodontic, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
buprenorphine and local anesthetic
Arm Type
Active Comparator
Arm Description
buprenorphine added to local anesthetic
Arm Title
sterile saline and local anesthetic
Arm Type
Placebo Comparator
Arm Description
sterile saline (placebo) added to local anesthetic
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
Buprenorphine plus local anesthetic
Intervention Type
Drug
Intervention Name(s)
Sterile saline
Intervention Description
Placebo 1,8 ml
Intervention Type
Drug
Intervention Name(s)
lidocaine, epinephrine (Local anesthetic)
Intervention Description
2% lidocaine 1:100,000 epinephrine
Primary Outcome Measure Information:
Title
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
Description
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.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

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