Clinical trial NCT02929602: Analgesic Use and Effectiveness for Dental Procedures
Official title: PRL0706: Analgesic Use and Effectiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: prescribing
effectiveness
dental
opioid
analgesic
Lead sponsor: Pearl Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2016-10-11
Enrollment: 2773
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dentist questionnaire
timeFrame: baseline
Secondary outcomes:
measure: Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale
timeFrame: 5 days after the dental procedure
measure: Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).
timeFrame: 5 days after the dental procedure
Other outcomes:
measure: Patient questionnaire - side effects of analgesics post dental procedure
timeFrame: 5 days post dental procedure
Locations:
city: New York
country: United States
facility: PEARL Network Sites
state: New York
Study officials:
affiliation: Pearl Network
name: Frederick A Curro, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.