Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
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ClinicalTrials.gov Identifier: NCT01490931 |
Recruitment Status :
Completed
First Posted : December 13, 2011
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
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Sponsor:
Hersh, Elliot V., DMD, MS, PhD
Information provided by (Responsible Party):
Hersh, Elliot V., DMD, MS, PhD
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Acute Pain |
Intervention |
Drug: Ketorolac Nasal Spray |
Enrollment | 28 |
Participant Flow
Recruitment Details | Consecutive patients in PENN periodontal clinic or faculty practice requiring 1 to 3 dental implants employing lidocaine with epinephrine for anesthesia without significant bone augmentation |
Pre-assignment Details | Subjects not experiencing moderate pain (at least 40 mm on the pain intensity VAS and moderate or severe pain on the 4-point categorical scale) within 4 hours of surgery were not dosed with ketorolac. Of the 28 enrolled subjects, 25 (89%) achieved at least moderate pain and were dosed. |
Arm/Group Title | Ketorolac Nasal Spray 31.5 mg (SPRIX) |
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Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours |
Period Title: Overall Study | |
Started | 25 |
Completed | 25 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Ketorolac Nasal Spray 31.5 mg (SPRIX) | |
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Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours |
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Overall Number of Baseline Participants | 25 | |
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Pilot Study. No power analysis performed.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
25 100.0%
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>=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | |
Female |
14 56.0%
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Male |
11 44.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 25 participants |
25 | ||
pain intensity on 100 mm visual analog scale (VAS). 0=No pain 100=worst possible pain
Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 25 participants | |
54.4 (14.3) |
Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
Name/Title: | Elliot V Hersh DMD, MS, PhD Professor of Pharmacology |
Organization: | Univeristy of Pennsylvania School of Dental Medicine |
Phone: | 215-898-9686 |
EMail: | evhersh@pobox.upenn.edu |
Publications of Results:
Other Publications:
Responsible Party: | Hersh, Elliot V., DMD, MS, PhD |
ClinicalTrials.gov Identifier: | NCT01490931 |
Other Study ID Numbers: |
SPRIX IMPLANT 001 |
First Submitted: | December 11, 2011 |
First Posted: | December 13, 2011 |
Results First Submitted: | February 24, 2014 |
Results First Posted: | May 9, 2014 |
Last Update Posted: | May 9, 2014 |