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Analgesic Use and Effectiveness for Dental Procedures

PRL0706: Analgesic Use and Effectiveness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02929602
Enrollment
2773
Registered
2016-10-11
Start date
2007-06-30
Completion date
2014-06-30
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

prescribing, effectiveness, dental, opioid, analgesic

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.

Interventions

None listed

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Pearl Network
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dentist questionnairebaselinedentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)

Secondary

MeasureTime frameDescription
Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale5 days after the dental procedureanticipated pain severity using the VAS-5 pain scale (1-5 scale)
Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).5 days after the dental procedure

Other

MeasureTime frameDescription
Patient questionnaire - side effects of analgesics post dental procedure5 days post dental procedure(Descriptive methods were used) to determine side effects: Yes/no, describe for Rx and OTC analgesic medications.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026