An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain

Condition(s) targeted: Other Acute Pain

Intervention: intranasal ketorolac (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Sharon Mace, MD, Principal Investigator, Affiliation: The Cleveland Clinic

Overall contact:
Sharon Mace, MD, Phone: 216-445-4598, Email: maces@ccf.org

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 18-64 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.

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline Vital Signs and Pain Scales After Drug Administration in Patients with Acute Pain Reporting to the ED

Secondary outcome: Changes in vital signs, nasal mucosa, and/or adverse events/side effects after drug administration in an acute care setting, the ED.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Sharon Mace, MD, Phone: 216-445-4598, Email: maces@ccf.org

Cleveland Clinic Emergency Department, Cleveland, Ohio 44195, United States

Starting date: November 2011
Last updated: November 14, 2011