Other Acute Pain
Conditions
Keywords
18 years and older,, previously healthy, men and nonpregnant women, emergency department
Brief summary
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.
Detailed description
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.
Interventions
DRUGintranasal ketorolac
15 mg
Sponsors
American Regent, Inc.
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is being seen in the emergency department (ED) in acute pain from an acute illness or injury (such as a kidney stone or an acute musculoskeletal injury) 2. Age ≥ 18 years and \< 65 years 3. Stable patient with stable vital signs, including not in shock (systolic BP \>90), not in respiratory failure, and not a multiple trauma patient 4. Mentally competent patient is able to understand the consent form 5. Baseline pain score is moderate to severe (e.g. on NRS ≥ 4 on a 0 to 10 NRS or ≥ 40 on a 0 to 100 NRS)
Exclusion criteria
1. Unstable patients 2. Multiple trauma patients 3. Patients with any allergies to ketorolac or any of the components in the nasal spray preparation 4. Patients with active peptic ulcer disease 5. Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS 6. Patients about to undergo major surgery 7. Patients with renal disease or at risk for renal failure due to volume depletion 8. Pregnant or nursing mothers 9. Patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, and/or those at high-risk of bleeding 10. Patient with a nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor) 11. Patient with any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert 12. History of chronic pain 13. History of drug abuse 14. History of significant neurologic disorder (could include diseases such as diabetic neuropathy, Parkinson's disease, etc) 15. History of significant psychiatric disorder 16. History of being on medications that may affect neurotransmitters (such as certain neurologic or psychiatric medications) 17. No immediate post-op patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Intranasal Ketorolac on Numeric Pain Scale | up to 4 hours | Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event/Side Effects | Up to 4 hours | Safety assessed by reporting of all adverse events and side effects. |
Countries
United States
Participant flow
Recruitment details
December 01, 2011 Emergency Department
Pre-assignment details
Chronic pain, critical illness
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Ketorolac (Sprix) FDA approved drug used in single arm study
intranasal ketorolac: 15 mg | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | Intranasal Ketorolac (Sprix) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 37.2 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 7 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
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)
Time frame: up to 4 hours
Population: 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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 10 | 10 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 9 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 8 | 12 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 7 | 5 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 6 | 5 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 5 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 4 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | REported Pain Score of 3 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 2 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 1 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | Reported Pain Score of 0 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | Baseline | No Rating | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 10 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 9 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 8 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 7 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 6 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 5 | 6 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 4 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | REported Pain Score of 3 | 4 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 2 | 5 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 1 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | Reported Pain Score of 0 | 4 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 20 minutes | No Rating | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 10 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 9 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 8 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 7 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 6 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 5 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 4 | 2 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | REported Pain Score of 3 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 2 | 4 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 1 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | Reported Pain Score of 0 | 6 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 40 minutes | No Rating | 10 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 10 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 9 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 8 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 7 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 6 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 5 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 4 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | REported Pain Score of 3 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 2 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 1 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | Reported Pain Score of 0 | 3 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 1 hour | No Rating | 29 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 10 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 9 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 8 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 7 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 6 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 5 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 4 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | REported Pain Score of 3 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 2 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 1 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | Reported Pain Score of 0 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 2 hoiurs | No Rating | 36 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 10 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 9 | 1 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 8 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 7 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 6 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 5 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 4 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | REported Pain Score of 3 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 2 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 1 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | Reported Pain Score of 0 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 3 hours | No Rating | 36 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 10 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 9 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 8 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 7 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 6 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 5 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 4 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | REported Pain Score of 3 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 2 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 1 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | Reported Pain Score of 0 | 0 Participants |
| Intranasal Ketorolac (Sprix) | Efficacy of Intranasal Ketorolac on Numeric Pain Scale | 4 hours | No Rating | 37 Participants |
Secondary
Adverse Event/Side Effects
Safety assessed by reporting of all adverse events and side effects.
Time frame: Up to 4 hours
Population: Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intranasal Ketorolac (Sprix) | Adverse Event/Side Effects | Reported a burning feeling | 7 Participants |
| Intranasal Ketorolac (Sprix) | Adverse Event/Side Effects | No adverse event/Side effect reported | 30 Participants |