An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Tre… (NCT01471639) | Clinical Trial Compass
CompletedNot Applicable
An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
United States37 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Age ≥ 18 years and \< 65 years
✓. Stable patient with stable vital signs, including not in shock (systolic BP \>90), not in respiratory failure, and not a multiple trauma patient
✓. Mentally competent patient is able to understand the consent form
✓. 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
✕. Unstable patients
✕. Multiple trauma patients
✕. Patients with any allergies to ketorolac or any of the components in the nasal spray preparation
✕. Patients with active peptic ulcer disease
✕
What they're measuring
1
Efficacy of Intranasal Ketorolac on Numeric Pain Scale