Acute Pain Clinical Trial
Official title:
Single-dose and Multi-dose Open-label Pilot Trial of the Analgesic Efficacy and Tolerability of Intranasal Ketorolac Tromethamine (SPRIX®) in Dental Implant Surgery Patients With Postoperative Pain.
Verified date | April 2014 |
Source | Hersh, Elliot V., DMD, MS, PhD |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: Key Inclusion Criteria 1. Male or female between 18 and 64 years of age. 2. Must sign informed consent prior to initiation of any study procedures. The subject must be able to understand and agree to cooperate with study requirements. 3. BMI between 19 and 29 kg/m2. 4. Must require the surgical placement of 1 - 3 dental implants that are being placed in a one or two stage non-immediately loaded surgical procedure employing 2% lidocaine and/or 4% articaine with epinephrine and/or 3% mepivacaine plain for local anesthesia. 5. Females of child-bearing potential must have a negative urine pregnancy test at screening and immediately prior to the initiation of dental implant surgery and must have been using adequate means of birth control (abstinence, oral contraceptive steroids, intrauterine device (IUD), etc.) for at least one month prior to study entry and during the study. 6. In the opinion of the investigators the subject can safely tolerate ketorolac and acetaminophen. Exclusion Criteria: Key Exclusion Criteria 1. Require the placement of more than 3 implants or require extensive bone grafting in addition to implant placement. 2. Need to administer anxiolytic/sedation drugs during surgery other than nitrous oxide/oxygen. 3. Need to administer the long acting local anesthetic bupivacaine with 1:200,000 epinephrine. 4. Implant(s) that are going to be immediately loaded on the day of surgery 5. Females that are pregnant or breast feeding 6. Allergies or hypersensitivity (aspirin sensitive asthma) to ketorolac, aspirin, ibuprofen, other NSAIDs, or acetaminophen. 7. History of gastrointestinal ulcers and/or bleeding. 8. On warfarin, dicumarol, clopidogrel or any other anticoagulant or antiplatelet therapy other than low dose (81 mg - 325 mg) aspirin. 9. Clinically significant kidney or liver disease where the intake of NSAIDs or acetaminophen would put the subject at undo risk. 10. Blood pressure greater than 160/95 at the time of screening or immediately before surgery. 11. Inflammation of the nasal mucosa or upper respiratory tract infection 12. Have ingested any analgesic agent within 48 hours of surgery. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania School of Dental Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Hersh, Elliot V., DMD, MS, PhD |
United States,
Al-Khabbaz AK, Griffin TJ, Al-Shammari KF. Assessment of pain associated with the surgical placement of dental implants. J Periodontol. 2007 Feb;78(2):239-46. — View Citation
Bockow R, Korostoff J, Pinto A, Hutcheson M, Secreto SA, Bodner L, Hersh EV. Characterization and treatment of postsurgical dental implant pain employing intranasal ketorolac. Compend Contin Educ Dent. 2013 Sep;34(8):570-6. — View Citation
Hersh EV, Levin LM, Adamson D, Christensen S, Kiersch TA, Noveck R, Watson G 2nd, Lyon JA. Dose-ranging analgesic study of Prosorb diclofenac potassium in postsurgical dental pain. Clin Ther. 2004 Aug;26(8):1215-27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period. | Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale | 20 minutes post dose | No |
Primary | Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period. | VAS pain intensity score at 40 minutes post-dose | 40 minutes post dose | No |
Primary | Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | VAS pain intensity score 60 minutes after dosing. | 60 minutes post dose | No |
Primary | Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 90 minutes post-dose | No | |
Primary | Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 2 Hours | No | |
Primary | Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 3 hours post-dose | No | |
Primary | Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 4 Hours post-dose | No | |
Primary | Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 5 Hours post-dose | No | |
Primary | Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period | 6 Hours post-dose | No | |
Secondary | The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients | Data will be obtained employing the well-described double stop watch technique | Censored at 6 hours | No |
Secondary | Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery. | Up to 5 hours after last suture is placed | No | |
Secondary | Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication. | Self explanatory | Up to 5 days | No |
Secondary | Median Onset of Meaningful Pain Relief | Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them. | At time of depressing meaningful relief stopwatch up to 6 hours. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT03825549 -
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
|
N/A | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Recruiting |
NCT05589246 -
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
|
N/A | |
Recruiting |
NCT05572190 -
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
|
Phase 1 | |
Terminated |
NCT04716413 -
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
|
Phase 4 | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Not yet recruiting |
NCT06317844 -
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
|
N/A | |
Withdrawn |
NCT02957097 -
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |