Trial | NCT02782286  Report issue

Title

Morphine Versus Ketorolac in Low Back Pain
The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
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).
Study Started
May 31
2016
Primary Completion
Sep 30
2016
Anticipated
Study Completion
Sep 30
2016
Anticipated
Last Update
May 25
2016
Estimate

Drug Ketorolac

The patients randomised to this arm will receive 30 mg intravenous ketorolac.

Drug Morphine

The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.

Ketorolac Active Comparator

The patients randomised to this arm will receive 30 mg intravenous ketorolac.

Morphine Active Comparator

The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.

Criteria 

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
No Results Posted