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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02782273
Other study ID # 1-4627
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received May 16, 2016
Last updated May 24, 2016
Start date May 2016
Est. completion date September 2016

Study information

Verified date May 2016
Source Bucharest Emergency Hospital
Contact Dan Marinescu, MD
Phone 0040741020848
Email danvmarinescu@gmail.com
Is FDA regulated No
Health authority Romania: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- clinical diagnosis of renal colic

- grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

- contraindications of ketorolac or opioids

- pregnancy

- allergies to ketorolac or opioids

- refusal of participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketorolac
The patients randomised to this arm they will receive 30 mg intravenous ketorolac.
Morphine
The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Loredana Ghinea

Outcome

Type Measure Description Time frame Safety issue
Primary Reducing the grade of pain To see the reducing of the pain on a scale 1-10 at two time points 15 minutes, 30 minutes No
Secondary Time of staying in emergency department 30 minutes, 1 hour, 2 hours No
Secondary The necessity of urology consult - interventional measures The patients will be called after 7 days to see if they needed urology consult and urological intervention 7 days No
Secondary The cost of each treatment To evaluate the costs of treatment of each type of drug and/or rescue therapy 1 hour No
Secondary The necessity to use rescue therapy - pain > 5 grade 30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale 30 minutes No
Secondary Side effects of each treatment 30 minutes Yes
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