Analgesic Use and Effectiveness for Dental Procedures

PRL0706: Analgesic Use and Effectiveness

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.

Study Overview

• Status: Completed
• Conditions: Pain

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 Type: Observational
• Enrollment (Actual): 2773

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • PEARL Network Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentist questionnaire	dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)	baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient questionnaire - side effects of analgesics post dental procedure	(Descriptive methods were used) to determine side effects: Yes/no, describe for Rx and OTC analgesic medications.	5 days post dental procedure

Collaborators and Investigators

• Sponsor: Pearl Network
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Frederick A Curro, DMD, PhD, Pearl Network

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: opioid; analgesic; effectiveness; dental; prescribing
• Other Study ID Numbers: PRL0706; U01DE016755 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will send to the NIDCR.