Morphine Versus Ketorolac in Low Back Pain

• ClinicalTrials.gov Identifier: NCT02782286
• Recruitment Status: Unknown
• First Posted: May 25, 2016
• Last Update Posted: May 25, 2016
• Sponsor: Loredana Ghinea
• Information provided by (Responsible Party): Loredana Ghinea, Bucharest Emergency Hospital

Tracking Information

• First Submitted Date: May 16, 2016
• First Posted Date: May 25, 2016
• Last Update Posted Date: May 25, 2016
• Study Start Date: May 2016
• Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2016)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 22, 2016)

• Time of staying in emergency department [ Time Frame: 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.
• The cost of each treatment [ Time Frame: 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
• Side effects of each treatment [ Time Frame: 30 minutes ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Morphine Versus Ketorolac in Low Back Pain
• Official Title: The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Low Back Pain

Intervention

• 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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 22, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02782286
• Other Study ID Numbers: 2-4627
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Loredana Ghinea, Bucharest Emergency Hospital
• Study Sponsor: Loredana Ghinea
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dan Marinescu, MD; Clinical Emergency Hospital Bucharest

• PRS Account: Bucharest Emergency Hospital
• Verification Date: May 2016