Clinical trial NCT03197311: A Mobile Application for Post-op Analgesic Consumption
Official title: A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Extraction Status Nos
Post Operative Pain
Patient Satisfaction
Narcotic Use
Mobile App
Keywords: Oral surgery
Medication adherence
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed.

In this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.

Detailed description: A pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting. Eligible consented subjects will be randomized into either the mobile app group or the control group. Both groups will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction. A total of 20 consecutive eligible patients will be enrolled in this pilot trial..

Eligibility criteria: Inclusion Criteria:

* Patients between the age of 18-40 years
* Patients who require two mandibular third molars extracted
* Patients with a smartphone

Exclusion Criteria:

* Patients taking any recreational drugs and medications for chronic pain

Primary outcomes:
measure: Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
timeFrame: At the end of 7 days
measure: Assessment of change in Postoperative pain control
timeFrame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Secondary outcomes:
measure: Satisfaction with the education received regarding the prescribed medications.
timeFrame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
measure: Use of the analgesic and post-op care education links on the mobile app.
timeFrame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Campus
state: Massachusetts
Study officials:
affiliation: Boston University
name: Radhika Chigurupati, DMD, MS
role: STUDY_DIRECTOR
References: