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| Name | Class |
|---|---|
| American Regent, Inc. | INDUSTRY |
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The purpose of this study is to determine the effectiveness, the safety, and the tolerability of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-65 who come to the ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the treatment of acute pain in the ED.
Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and oral pill form, has been shown to be safe and effective in treating acute pain.
This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray will have the same benefit in decreasing patient's pain.
Adults between the ages of 18-65 were being seen in the emergency department of a single large tertiary care hospital with acute pain (moderate to severe 4-10 NRS scale). Those who met inclusion criteria were approached. Informed written consent was obtained from all participants. The study was approved by local Institutional Review Board (IRB). Demographics (age, gender, ethnicity) were recorded. Baseline pain scores on NRS were obtained prior to administration of the drug. Pain scores (NRS) after administration of the drug (intranasal ketorolac) were recorded. All adverse events/side effects were recorded. Data was obtained for the time the individual patient was in the emergency department being treated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal ketorolac (Sprix) | Experimental | FDA approved drug used in single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal ketorolac | Drug | 15 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain) | up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event/Side Effects | Safety assessed by reporting of all adverse events and side effects. | Up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Mace, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22711895 | Background | Pfaffenrath V, Fenzl E, Bregman D, Farkkila M. Intranasal ketorolac tromethamine (SPRIX(R)) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a phase II clinical trial. Cephalalgia. 2012 Jul;32(10):766-77. doi: 10.1177/0333102412451359. Epub 2012 Jun 18. |
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Chronic pain, critical illness
December 01, 2011 Emergency Department
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Ketorolac (Sprix) | FDA approved drug used in single arm study intranasal ketorolac: 15 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Ketorolac (Sprix) | FDA approved drug used in single arm study intranasal ketorolac: 15 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain) | Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain) | Posted | Count of Participants | Participants | up to 4 hours |
|
|
7 months
Definition same as Clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Ketorolac (Sprix) | FDA approved drug used in single arm study intranasal ketorolac: 15 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort (burning feeling of nasal mucosa) | Skin and subcutaneous tissue disorders | SNOMED CT | Non-systematic Assessment | 7 individual felt discomfort (a burning feeling) of the nasal mucosa. This resolved quickly, within minutes. Inspection of the nasal mucosa showed no visible abnormalities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Mace MD | Cleveland Clinic Healthcare System | 216-445-4598 | maces@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2011 | Aug 16, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2011 | Aug 16, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Secondary | Adverse Event/Side Effects | Safety assessed by reporting of all adverse events and side effects. | Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac | Posted | Count of Participants | Participants | Up to 4 hours |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 7 |
| 37 |
|
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| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| Reported Pain Score of 7 |
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| Reported Pain Score of 6 |
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| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|
| Reported Pain Score of 7 |
|
| Reported Pain Score of 6 |
|
| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|
| Reported Pain Score of 7 |
|
| Reported Pain Score of 6 |
|
| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|
| Reported Pain Score of 7 |
|
| Reported Pain Score of 6 |
|
| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|
| Reported Pain Score of 7 |
|
| Reported Pain Score of 6 |
|
| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|
| Reported Pain Score of 7 |
|
| Reported Pain Score of 6 |
|
| Reported Pain Score of 5 |
|
| Reported Pain Score of 4 |
|
| REported Pain Score of 3 |
|
| Reported Pain Score of 2 |
|
| Reported Pain Score of 1 |
|
| Reported Pain Score of 0 |
|
| No Rating |
|