Morphine Versus Ketorolac in Low Back Pain

Phase 4

• Conditions: Low Back Pain
• Interventions: Drug: Morphine; Drug: Ketorolac

• Registration Number: NCT02782286
• Lead Sponsor: Loredana Ghinea

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).

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-22
• Last Update Submitted: 2016-05-22
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketorolac	Morphine	The patients randomised to this arm will receive 30 mg intravenous ketorolac.
Morphine	Ketorolac	The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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