A Mobile Application for Post-op Analgesic Consumption

NCT ID: NCT03197311

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-09-30

Brief Summary

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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

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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..

Conditions

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Tooth Extraction Status Nos Post Operative Pain Patient Satisfaction Narcotic Use Mobile App

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mobile app group

In addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery.

Group Type EXPERIMENTAL

Mobile app

Intervention Type OTHER

A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery.

Control group

The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery..

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile app

A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Radhika Chigurupati, DMD, MS

Role: STUDY_DIRECTOR

Boston University

Locations

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Boston University Medical Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-36258

Identifier Type: -

Identifier Source: org_study_id

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