Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790812
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2020-11-05
Brief Title:
Preemptive Analgesia With Celecoxib for Acute Dental Pain Management
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Single Dose Oral Celecoxib With or Without Acetaminophen for Acute Post-operative Pain Following Impacted Third Molar Surgery
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effect on postoperative pain of a single agent nonsteroidal anti-inflammatory drug NSAID celecoxib plus placebo to an NSAID combination celecoxib plus acetaminophen administered preemptively to patients prior to impacted third molar surgery
Detailed Description:
This randomized double-blind placebo-controlled prospective clinical trial is designed to compare the postoperative pain reduction of a single agent nonsteroidal anti-inflammatory drug NSAID and NSAID combination regimen administered preemptively Subjects will be given a single oral dose of a cyclooxygenase-2 COX-2 selective inhibitor celecoxib 200mg or celecoxib 200 mg in combination with acetaminophen APAP 1000 mg 30 to 60 minutes prior to the procedure Oral surgery involving at least one impacted mandibular third molar will be performed using a combination of intravenous sedation and local anesthesia following UTHealth School of Dentistry UTSD surgical protocol All subjects will be released with identical postoperative instructions and prescriptions for pain management Nonopioid pain management will be prescribed as follows 600mg ibuprofen with 500 mg APAP every 6 hours for the first 3 days then as needed for pain Subjects will be asked to document medication consumption postoperative pain and complications for the following 3 days using a Qualtrics survey An oral and maxillofacial surgery resident or faculty on call can offer emergency intervention with prescription of an opioid analgesic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None