Pain
Conditions
Brief summary
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
Detailed description
Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an analgesic ceiling with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages. Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
Interventions
DRUG10 mg of Ketorolac
Patients will receive 10 mg of Ketorolac for pain control.
DRUG15 mg of Ketorolac
Patients will receive 15mg of Ketorolac for pain control.
DRUG30 mg of Ketorolac
Patients will receive 30mg of Ketorolac for pain control.
Sponsors
Antonios Likourezos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.
Exclusion criteria
Age \>65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 30 Minutes | 30 minutes | Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effect of Headache | 120 minutes | The number of study patients who reported headache after administration of medication |
| Adverse Effect of Dizziness | 120 minutes | the number of study patients who reported having dizziness after administration of medication. |
| Adverse Effect of Nausea | 120 minutes | The number of study patients who reported nausea after administration of medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - 10 mg of Ketorolac Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control. | 80 |
| Group 2 - 15mg Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control. | 80 |
| Group 3 - 30mg Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control. | 80 |
| Total | 240 |
Baseline characteristics
| Characteristic | Group 1 - 10 mg of Ketorolac | Group 2 - 15mg | Group 3 - 30mg | Total |
|---|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 12.1 | 40.1 years STANDARD_DEVIATION 12.1 | 38.8 years STANDARD_DEVIATION 11.6 | 40.2 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 80 participants | 80 participants | 80 participants | 240 participants |
| Sex: Female, Male Female | 41 Participants | 48 Participants | 43 Participants | 132 Participants |
| Sex: Female, Male Male | 39 Participants | 32 Participants | 37 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 80 |
Outcome results
Primary
Pain Score at 30 Minutes
Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - 10 mg of Ketorolac | Pain Score at 30 Minutes | 5.14 pain score | Standard Deviation 2.7 |
| Group 2 - 15mg | Pain Score at 30 Minutes | 5.05 pain score | Standard Deviation 2.56 |
| Group 3 - 30mg | Pain Score at 30 Minutes | 4.81 pain score | Standard Deviation 2.85 |
Secondary
Adverse Effect of Dizziness
the number of study patients who reported having dizziness after administration of medication.
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - 10 mg of Ketorolac | Adverse Effect of Dizziness | 14 Participants |
| Group 2 - 15mg | Adverse Effect of Dizziness | 16 Participants |
| Group 3 - 30mg | Adverse Effect of Dizziness | 12 Participants |
Secondary
Adverse Effect of Headache
The number of study patients who reported headache after administration of medication
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - 10 mg of Ketorolac | Adverse Effect of Headache | 8 Participants |
| Group 2 - 15mg | Adverse Effect of Headache | 2 Participants |
| Group 3 - 30mg | Adverse Effect of Headache | 3 Participants |
Comparison: The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.p-value: 0.783ANOVA
Secondary
Adverse Effect of Nausea
The number of study patients who reported nausea after administration of medication
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - 10 mg of Ketorolac | Adverse Effect of Nausea | 9 Participants |
| Group 2 - 15mg | Adverse Effect of Nausea | 11 Participants |
| Group 3 - 30mg | Adverse Effect of Nausea | 8 Participants |