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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02929602
Study type Observational
Source Pearl Network
Contact
Status Completed
Phase N/A
Start date June 2007
Completion date June 2014

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