Morphine Versus Ketorolac in Low Back Pain

NCT ID: NCT02782286

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketorolac

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Morphine

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

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loredana Ghinea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Loredana Ghinea

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dan Marinescu, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Emergency Hospital Bucharest

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dan Marinescu, MD

Role: CONTACT

0040741020848

Vlad A Maltezeanu, MD

Role: CONTACT

0040720943180

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2-4627

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.