Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients

NCT01490931 | Completed Phase 4 Results DMC

• 1 other identifier: SPRIX IMPLANT 001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pain

Keywords

acute pain; dental pain; intranasal ketorolac; dental implant surgery

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

  2 Hours

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients

  Censored at 6 hours

• 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

• Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.

  Up to 5 days

• Median Onset of Meaningful Pain Relief

  At time of depressing meaningful relief stopwatch up to 6 hours.

Study Arms (1)

Ketorolac nasal spray 31.5 mg

EXPERIMENTAL

Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.

Drug: Ketorolac Nasal Spray

Interventions

Ketorolac Nasal Spray DRUG

15.75 mg nasal spray delivery to each nostril no more than every six hours

Also known as: SPRIX

Ketorolac nasal spray 31.5 mg

Eligibility Criteria

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

You may qualify if:

• Male or female between 18 and 64 years of age.
• 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.
• BMI between 19 and 29 kg/m2.
• 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.
• 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.
• In the opinion of the investigators the subject can safely tolerate ketorolac and acetaminophen.

You may not qualify if:

• Require the placement of more than 3 implants or require extensive bone grafting in addition to implant placement.
• Need to administer anxiolytic/sedation drugs during surgery other than nitrous oxide/oxygen.
• Need to administer the long acting local anesthetic bupivacaine with 1:200,000 epinephrine.
• Implant(s) that are going to be immediately loaded on the day of surgery
• Females that are pregnant or breast feeding
• Allergies or hypersensitivity (aspirin sensitive asthma) to ketorolac, aspirin, ibuprofen, other NSAIDs, or acetaminophen.
• History of gastrointestinal ulcers and/or bleeding.
• On warfarin, dicumarol, clopidogrel or any other anticoagulant or antiplatelet therapy other than low dose (81 mg - 325 mg) aspirin.
• Clinically significant kidney or liver disease where the intake of NSAIDs or acetaminophen would put the subject at undo risk.
• Blood pressure greater than 160/95 at the time of screening or immediately before surgery.
• Inflammation of the nasal mucosa or upper respiratory tract infection
• Have ingested any analgesic agent within 48 hours of surgery.

Sponsors & Collaborators

• Hersh, Elliot V., DMD, MS, PhD: lead

Study Sites (1)

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104-6030, United States

Location

Related Publications (3)

• 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. doi: 10.1902/jop.2007.060032.

  PMID: 17274712 BACKGROUND

• 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. doi: 10.1016/s0149-2918(04)80033-x.

  PMID: 15476903 BACKGROUND

• 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.

  PMID: 24564610 RESULT

MeSH Terms

Conditions

Acute Pain; Toothache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Limitations and Caveats

The major weakness of this study was its open-label design and lack of a placebo control and an active comparator drug. The study was also not powered to determine differences between the sites of implant placement and the number of implants placed.

Results Point of Contact

• Title: Elliot V Hersh DMD, MS, PhD Professor of Pharmacology
• Organization: Univeristy of Pennsylvania School of Dental Medicine

evhersh@pobox.upenn.edu

215-898-9686

Study Officials

• Elliot V Hersh, DMD, MS, PhD

  Univeristy of Pennsylvania School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2011
• First Posted: December 13, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (1)