Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

NCT03268278 | Terminated Phase 1

• 1 other identifier: UHClevelandMCBupStudy
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

analgesia; endodontic; postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Study Arms (2)

buprenorphine and local anesthetic

ACTIVE COMPARATOR

buprenorphine added to local anesthetic

Drug: Buprenorphine; Drug: lidocaine, epinephrine (Local anesthetic)

sterile saline and local anesthetic

PLACEBO COMPARATOR

sterile saline (placebo) added to local anesthetic

Drug: Sterile saline; Drug: lidocaine, epinephrine (Local anesthetic)

Interventions

Buprenorphine DRUG

Buprenorphine plus local anesthetic

buprenorphine and local anesthetic

Sterile saline DRUG

Placebo 1,8 ml

sterile saline and local anesthetic

lidocaine, epinephrine (Local anesthetic) DRUG

2% lidocaine 1:100,000 epinephrine

buprenorphine and local anesthetic; sterile saline and local anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy, allergy to buprenorphine, allergy to local anesthetic

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Buprenorphine; Lidocaine; Epinephrine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 31, 2017
• Study Start: April 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)