Analgesic Use and Effectiveness for Dental Procedures

Completed

• Conditions: Pain

• Registration Number: NCT02929602
• Lead Sponsor: Pearl Network

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.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2011-11
• Study Completion: 2014-06
• Study First Submitted: 2016-02-05
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2773

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dentist questionnaire	baseline	dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)

Secondary Outcome Measures

Name	Time	Method
Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).	5 days after the dental procedure
Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale	5 days after the dental procedure	anticipated pain severity using the VAS-5 pain scale (1-5 scale)

Trial Locations

Locations (1)

PEARL Network Sites; 🇺🇸 New York, New York, United States