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Phase 4 N=240 Randomized Quadruple-blind Treatment

A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management

Pain

Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Pain Score at 30 Minutes — 5.14; 5.05; 4.81 pain score

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
10 mg of Ketorolac (Drug); 15 mg of Ketorolac (Drug); 30 mg of Ketorolac (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Antonios Likourezos
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Score at 30 Minutes
5.14; 5.05; 4.81
SECONDARY
Adverse Effect of Dizziness
14; 16; 12
SECONDARY
Adverse Effect of Nausea
9; 11; 8
SECONDARY
Adverse Effect of Headache
8; 2; 3 .783

Summary

Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Eligibility Criteria

Inclusion Criteria

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria

Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02078492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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