Clinical trial NCT01471639: An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Official title: A Prospective, Open-label, Nonrandomized Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Acute Pain
Keywords: 18 years and older,
previously healthy
men and nonpregnant women
emergency department
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Regent, Inc.
First posted: 2011-11-15
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Intranasal Ketorolac on Numeric Pain Scale
timeFrame: up to 4 hours
Secondary outcomes:
measure: Adverse Event/Side Effects
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sharon Mace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfaffenrath V, Fenzl E, Bregman D, Farkkila M. Intranasal ketorolac tromethamine (SPRIX(R)) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a phase II clinical trial. Cephalalgia. 2012 Jul;32(10):766-77. doi: 10.1177/0333102412451359. Epub 2012 Jun 18.