Morphine Versus Ketorolac in Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02782286
• Other study ID #: 2-4627
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 16, 2016
• Last updated: May 22, 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 low back pain.

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).

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 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

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
• Morphine
The patients randomised to this arm 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, 3 hours	No
Secondary	The necessity neurosurgery consult - questionnaire	The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon.	1 month	No
Secondary	The cost of each treatment		1 hour	No
Secondary	The necessity to use rescue therapy	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