A Mobile Application for Post-op Analgesic Consumption

NCT03197311 | Withdrawn

• 1 other identifier: H-36258
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oral surgery; Medication adherence

Outcome Measures

Primary Outcomes (2)

• Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.

  Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.

  At the end of 7 days

• Assessment of change in Postoperative pain control

  The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. Lower scores are associated with less pain..

  Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)

Secondary Outcomes (2)

• Satisfaction with the education received regarding the prescribed medications.

  Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)

• Use of the analgesic and post-op care education links on the mobile app.

  Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)

Study Arms (2)

Mobile app group

EXPERIMENTAL

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.

Other: Mobile app

Control group

NO INTERVENTION

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..

Interventions

Mobile app 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.

Mobile app group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients taking any recreational drugs and medications for chronic pain

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction; Medication Adherence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care

Study Officials

• Radhika Chigurupati, DMD, MS

  Boston University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: October 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)