Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department: A Randomized Non-inferiority Trial

Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department: A Randomized Non-inferiority 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.

Pain control is one of the problems in emergency departments (EDs). Analgesics in the intranasal (IN) form have been come into interest and focus because of their ease of application and effectiveness. Recently, IN ketorolac at 30mg has been turned out to have comparable efficacy with parenteral forms. Considering the ceiling effect of the ketorolac, we are to study whether lower dose of 20mg for pain management is equally effective as 30mg dose.

Our study is a multicenter, prospective, randomized, double blind, parallel group non inferiority clinical trial conducted in three EDs. Eligible participants are adults aged 18-65 years presenting with acute moderate to severe pain [numeric rating scale (NRS)≥4]. Participants will be randomized to receive atomized IN ketorolac 20 mg or 30 mg. Primary outcome is change in pain reduction at 30 minutes post administration. Secondary outcomes include pain reduction at 15, 45, and 60 minutes, requirement for rescue analgesia (IV morphine 0.1 mg/kg available at 30), gastrointestinal and other adverse effects, and patient satisfaction.

Inclusion Criteria:

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)

Exclusion Criteria:

Active peptic ulcer disease (PUD) History of hypersensitivity to NSAIDs Pregnancy and breastfeeding Renal failure Hepatic failure Patients who have received analgesics within the past 6 hours Nasal congestion Upper respiratory tract infection Patients with a history of kidney transplantation Active gastrointestinal bleeding Systolic blood pressure less than 90 mmHg or greater than 180 mmHg Heart rate less than 50 per minute or greater than 150 per minute Concurrent use of NSAIDs or anticoagulant drugs Inability to provide informed consent Anatomical abnormalities of the nose or skull base (congenital or acquired) Hyperreactive airway disease such as severe asthma Coagulation disorders Intracranial hemorrhage Suspected aortic dissection Suspected rupture of abdominal aortic aneurysm History of gastrointestinal perforation Gastrointestinal bleeding within the past month Chronic pain disorders Substance misuse Immediate opioid necessity Altered mental status Any pain that is considered to be not appropriate for receiving NSAIDS by emergency physician