The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
173
31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
Intranasal (IN) placebo
Volker Pfaffenrath
Munich, Bavaria, Germany
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 2 hours after dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 0.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 1 hour post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 1.5 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 3 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
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Time frame: 4 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 24 hours post-dosing
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time frame: 48 hours post-dosing