Clinical Trial: Morphine Versus Ketorolac in Renal Colic

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Analgesic Effects of Morphine Versus Ketorolac in Renal Colic

Brief Summary: The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.

Detailed Summary:

The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).


Sponsor: Loredana Ghinea

Current Primary Outcome: Reducing the grade of pain [ Time Frame: 15 minutes, 30 minutes ]

To see the reducing of the pain on a scale 1-10 at two time points


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time of staying in emergency department [ Time Frame: 30 minutes, 1 hour, 2 hours ]
  • The necessity of urology consult - interventional measures [ Time Frame: 7 days ]
    The patients will be called after 7 days to see if they needed urology consult and urological intervention
  • The cost of each treatment [ Time Frame: 1 hour ]
    To evaluate the costs of treatment of each type of drug and/or rescue therapy
  • The necessity to use rescue therapy - pain > 5 grade [ Time Frame: 30 minutes ]
    30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale
  • Side effects of each treatment [ Time Frame: 30 minutes ]


Original Secondary Outcome: Same as current

Information By: Bucharest Emergency Hospital

Dates:
Date Received: May 16, 2016
Date Started: May 2016
Date Completion: September 2016
Last Updated: May 24, 2016
Last Verified: May 2016