Analgesic Use and Effectiveness for Dental Procedures

Pain Clinical Trial

Official title:

PRL0706: Analgesic Use and Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929602
• Other study ID #: PRL0706
• Secondary ID: U01DE016755
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: October 7, 2016
• Start date: June 2007
• Est. completion date: June 2014

Study information

• Verified date: October 2016
• Source: Pearl Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2773
• Est. completion date: June 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	PEARL Network Sites	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pearl Network	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Dentist questionnaire	dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)	baseline	No
Secondary	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	No
Secondary	Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).		5 days after the dental procedure	No