About this trial
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-65 years
Weight > 50 kg
Able to provide informed consent
Acute pain (<48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)
Disqualifiers
Active peptic ulcer disease (PUD)
History of hypersensitivity to NSAIDs
Pregnancy and breastfeeding
Renal failure
Trial design
Parallel
Treatments tested in this trial
20mg intranasal ketorolac
Drug20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
30mg Intranasal Ketorolac
Drug30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
Treatment groups
Trial outcomes
Primary outcomes
Pain score at 30 minutes
Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)
Secondary outcomes
Pain score at 15 minutes
Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)
Pain score at 45 minutes
Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)
Pain score at 60 minutes
Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)
Need for rescue analgesia
IV morphine 0.1 mg/kg will be available at 30 minutes in cases of patients request
Locations
Sponsors and contacts
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