Morphine Versus Ketorolac in Low Back Pain

May 22, 2016 updated by: Loredana Ghinea

The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Active Comparator: Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
Drug: Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing the grade of pain
Time Frame: 15 minutes, 30 minutes
To see the reducing of the pain on a scale 1-10 at two time points
15 minutes, 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of each treatment
Time Frame: 30 minutes
30 minutes
Time of staying in emergency department
Time Frame: 30 minutes, 1 hour, 2 hours, 3 hours
30 minutes, 1 hour, 2 hours, 3 hours
The necessity neurosurgery consult - questionnaire
Time Frame: 1 month
The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon.
1 month
The cost of each treatment
Time Frame: 1 hour
1 hour
The necessity to use rescue therapy
Time Frame: 30 minutes
30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loredana Ghinea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 22, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-4627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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