Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Introduction: Pain is a common reason for individuals to seek health care, especially
emergency care. Ketorolac has numerous advantages over other pain medications, especially the
opioids. The intranasal administration of ketorolac has been shown to be safe and effective
in the treatment of postoperative pain following major abdominal surgery and post dental
surgery, but there have been no studies evaluating the use of intranasal ketorolac for the
treatment of acute renal colic pain in the emergency department.
Methods: This is a double blinded randomized controlled trial. two hundred renal colic
patients presented to the emergency department will be randomized to intervention (30 mg
intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and
after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient,
attending physician and administering nurse will be blinded throughout the study. The
analgesic effects will be assessed by several measures including pain relief, pain intensity
difference, global pain evaluation, global assessment of analgesia, and the summed pain
intensity difference. The safety will be assessed by documentation of adverse events, vital
signs, and clinical assessment before and after drug administration.
Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac
tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to
severe renal colic.
Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale
(VAS).
Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge
and recurrent visit within 24 hours.
Patient Population: Adults (from age 18 to 64 years) who presents to emergency department
(ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive
of renal colic (visual analog scale 7 or more).
Intervention: Single dose of intranasal ketorolac 30mg.
Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after
intervention. Number and dosage of rescue medication, any reported events by patient or
attending physician will be documented.
Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given,
tolerability and safety evaluation.