Low Back Pain
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 low back pain.
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 low back pain. 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 : acetaminophen 1 g, sodic metamizole 1g both diluted in 500 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).
Interventions
DRUGKetorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
DRUGMorphine
The patients randomised to this arm 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 musculoskeletal low back pain * grade 5 pain on a 1-10 visual pain scale
Exclusion criteria
* contraindications of ketorolac or opioids * pregnancy * known allergies to ketorolac or opioids * post-traumatic low back pain * 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, 3 hours | — |
| The necessity neurosurgery consult - questionnaire | 1 month | The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon. |
| The cost of each treatment | 1 hour | — |
| The necessity to use rescue therapy | 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 ContactVlad A Maltezeanu, MD
Outcome results
None listed