Analgesic Use and Effectiveness for Dental Procedures

NCT ID: NCT02929602

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2773 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2014-06-30

Brief Summary

Opioid analgesics prescribed by dentists may contribute to the larger national issue of the use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the use of opioids. This study used both dentist and patient input to evaluate the use of opioid and over-the-counter analgesics following one of seven coded common dental procedures. The study includes a five day patient follow up assessment of the effectiveness of the analgesic. Baseline questionnaires were completed by eligible participants, and they responded to the day 5 follow up questionnaires.

Detailed Description

Specific Aims The overall objective of the proposed study is to determine (1) the pattern of analgesic prescriptions (Rx and OTC) and recommendations (OTC) in dental practices; and (2) the effectiveness of and side effects associated with these medications as measured by patientreported outcomes (PROs).

Specific Aim 1: To document (a) dentists' postprocedural prescriptions and recommendations for analgesic medication: and (b) the effectiveness of these medications and side effects associated with their use as measured by PROs.

Specific Aim 2: To analyze by procedure class and anticipated pain severity the PROs of Rx and OTC analgesic medications.

Specific Aim 3: Determine the incidence of analgesic side effects of Rx and OTC analgesic medications.

The outcomes of Specific Aims 1-3 will be:

• The distribution of dentists' Rx/OTC prescriptions/recommendations by dentists for anticipated pain severity.
• The effectiveness of different types of Rx and OTC analgesics (e.g., Rx NSAIDs vs. OTC NSAIDs, Rx NSAIDs vs. Rx narcotics) by procedure class and anticipated pain severity.
• The incidence of analgesic side effects for Rx and OTC analgesics. Analysis of the results and methods of the proposed research will furthermore serve as guidance in designing a randomized PBRN clinical trial comparing the efficacy of and complications associated with two or more analgesics.

Conditions

Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Presence of erupted second molar teeth.

2. Scheduled for treatment in one procedure of the following six procedure classes:

extraction, endodontic therapy, pulp capping, crown preparation, periodontal surgery, abscess treatment

3. Expected by the P-I to experience postoperative pain sufficient to require an analgesic

4. Permanent dentition (erupted 2nd molar teeth)

5. Capacity to judge pain level

6. Ability and willingness to give verbal consent

Exclusion Criteria

1. Under treatment for medical disorders, including dementia, Parkinson's disease, depression, severe anxiety, or any other medical condition, that, in the opinion of the P-I, would affect the subject's judgment of postoperative pain

2. Current participation in another dental or medical research study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Pearl Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick A Curro, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pearl Network

Locations

PEARL Network Sites

New York, New York, United States

Countries

United States

References

Wong YJ, Keenan J, Hudson K, Bryan H, Naftolin F, Thompson VP, Craig RG, Vena D, Collie D, Wu H, Matthews AG, Grill AC, Curro FA. Opioid, NSAID, and OTC Analgesic Medications for Dental Procedures: PEARL Network Findings. Compend Contin Educ Dent. 2016 Nov/Dec;37(10):710-718.

Reference Type: DERIVED

PMID: 27875056 (View on PubMed)

Other Identifiers

U01DE016755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRL0706

Identifier Type: -

Identifier Source: org_study_id