Renal Colic
Conditions
Keywords
ketorolac, pain relieve, morphine
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 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).
Interventions
DRUGKetorolac
The patients randomised to this arm they will receive 30 mg intravenous ketorolac.
DRUGMorphine
The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.
Sponsors
Loredana Ghinea
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing the grade of pain | 15 minutes, 30 minutes | To see the reducing of the pain on a scale 1-10 at two time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of staying in emergency department | 30 minutes, 1 hour, 2 hours | — |
| The necessity of urology consult - interventional measures | 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 | 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 | 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 | 30 minutes | — |
Contacts
Primary ContactDan Marinescu, MD
Backup ContactLoredana Ghinea, MD
Outcome results
None listed