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Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketorolac Nasal Spray

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring acute pain, dental pain, intranasal ketorolac, dental implant surgery

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Key Inclusion Criteria

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.
-

Exclusion Criteria:

Key Exclusion Criteria

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.
-

Sites / Locations

University of Pennsylvania School of Dental Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketorolac nasal spray 31.5 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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.

Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

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

Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

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

Secondary Outcome Measures

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

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.

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

Self explanatory

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.

Full Information

NCT ID

NCT01490931

First Posted

December 11, 2011

Last Updated

April 11, 2014

Sponsor

Hersh, Elliot V., DMD, MS, PhD

1. Study Identification

Unique Protocol Identification Number

NCT01490931

Brief Title

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hersh, Elliot V., DMD, MS, PhD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES Overall Objectives The purpose of this pilot study will be to evaluate the analgesic efficacy and tolerability of intranasal ketorolac employed at doses and dosing intervals stated in the package insert in patients experiencing moderate to severe pain following dental implant surgery. This open label study should provide data that will allow us to estimate sample size for a future placebo-controlled trial in the dental implant surgery population. Primary Outcome Variable(s) To determine if intranasal ketorolac significantly reduces pain intensity scores when compared to baseline pain intensity as measured by the area under the 6-hour pain intensity difference (SPID-6). Secondary Outcome Variable(s) To determine the median onset of first perceptible, confirmed first perceptible, and meaningful pain relief of intranasal ketorolac in dental implant surgery patients. To compare mean post-dose pain intensity scores at each time-point with the baseline pain intensity score during the initial 6-hour evaluation period. To calculate the area under the 6-hour pain relief time action curve (TOTPAR-6) for intranasal ketorolac. To calculate the 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. To determine the mean number of days of analgesic dosing in dental implant surgery patients when employing intranasal ketorolac as their pain medication. To determine the number of patients taking rescue medication (acetaminophen 650 mg) and the mean number of rescue medication doses taken in dental implant surgery patients when employing intranasal ketorolac as their pain medication. To determine the overall tolerability of intranasal ketorolac in dental implant surgery patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

Keywords

acute pain, dental pain, intranasal ketorolac, dental implant surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketorolac nasal spray 31.5 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketorolac Nasal Spray

Other Intervention Name(s)

SPRIX

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.

Description

Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale

Time Frame

20 minutes post dose

Title

Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.

Description

VAS pain intensity score at 40 minutes post-dose

Time Frame

40 minutes post dose

Title

Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Description

VAS pain intensity score 60 minutes after dosing.

Time Frame

60 minutes post dose

Title

Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Time Frame

90 minutes post-dose

Title

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

Time Frame

2 Hours

Title

Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Time Frame

3 hours post-dose

Title

Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Time Frame

4 Hours post-dose

Title

Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period

Time Frame

5 Hours post-dose

Title

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

Time Frame

6 Hours post-dose

Secondary Outcome Measure Information:

Title

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

Description

Data will be obtained employing the well-described double stop watch technique

Time Frame

Censored at 6 hours

Title

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.

Time Frame

Up to 5 hours after last suture is placed

Title

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

Description

Self explanatory

Time Frame

Up to 5 days

Title

Median Onset of Meaningful Pain Relief

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Key Inclusion Criteria 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. - Exclusion Criteria: Key Exclusion Criteria 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elliot V Hersh, DMD, MS, PhD

Organizational Affiliation

Univeristy of Pennsylvania School of Dental Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania School of Dental Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-6030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17274712

Citation

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.

Results Reference

background

PubMed Identifier

15476903

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

Results Reference

background

PubMed Identifier

24564610

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.

Results Reference

result

Links:

URL

http://www.drugs.com/sprix.html

Description

SPRIX prescribing information

Learn more about this trial

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients

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