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NCT01490931 · ClinicalTrials.gov registry record · Phase 4
Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
A Phase 4 study, sponsored by Hersh, Elliot V., DMD, MS, PhD.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01490931 is a Phase 4 study that has completed, run by Hersh, Elliot V., DMD, MS, PhD. The registered enrollment target is 28 participants.
The verdict
NCT01490931, a Phase 4 study, has completed, sponsored by Hersh, Elliot V., DMD, MS, PhD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
The surgical placement of dental implants is presently a common procedure performed by oral surgeons, periodontists, and general dentists. The surgery can be performed under local anesthesia and involves the incision of soft tissue to expose the underlying bone, preparation of the implant site using a specialized surgical drill, and.screwing the implant into bone using a specialized headpiece. Dental implant patients experience postoperative pain yet there are no studies in the literature which have evaluated the efficacy of analgesics in this patient population. The current pilot study will evaluate the analgesic effects and tolerability of a recently FDA-approved analgesic formulation of intranasal ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2 hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be recorded when and if they occur. Patients will then transition to a multi-dose phase where they will be allowed to dose with ketorolac as indicated in the package insert (up to 4 times per day for 5 days). Patients will record the time of each dose, a daily assessment of overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650 mg) on a take home diary.
Interventions
- DRUG Ketorolac Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01490931
The ClinicalTrials.gov registry entry for NCT01490931 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hersh, Elliot V., DMD, MS, PhD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketorolac Nasal Spray is the first listed.
NCT01490931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01490931 about?
NCT01490931 is a clinical study titled "Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients". The surgical placement of dental implants is presently a common procedure performed by oral surgeons, periodontists, and general dentists. The surgery can be performed under local anesthesia and involves the incision of soft tissue to expose the underlying bone, preparation of the implant site using...
What is the current status of trial NCT01490931?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2011-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01490931?
The interventions under investigation include: Ketorolac Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT01490931?
This trial is sponsored by Hersh, Elliot V., DMD, MS, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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