Post Operative Pain Clinical Trial
Official title:
A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
NCT number | NCT03197311 |
Other study ID # | H-36258 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | September 2020 |
Verified date | October 2019 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston University Medical Campus | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Satisfaction with the education received regarding the prescribed medications. | Assessment of patient satisfaction using a survey. For the subjects in the experimental group, they will be asked to complete a emoticon survey on the app which would correspond to the following descriptions: Excellent=4, good=3, average=2, poor=1.The subjects in the control group will be asked the same question as part of the post satisfaction survey without the emoticons as a sentence question. A lower score indicates low satisfaction. | Daily for 7 days post-op (experimental group) and At the end of 7 days (control group) | |
Secondary | Use of the analgesic and post-op care education links on the mobile app. | Educational links will be available to view as part of the app and usage will be monitored by website traffic. Higher numbers would indicate greater usage of educational links. | Daily for 7 days post-op (experimental group) and At the end of 7 days (control group) |
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