NCT02782286

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 low-back-pain

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4 low-back-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 16, 2016

Last Update Submit

May 22, 2016

Conditions

Low Back Pain

Keywords

ketorolacpain relievemorphine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Time of staying in emergency department

    30 minutes, 1 hour, 2 hours, 3 hours

  • The necessity neurosurgery consult - questionnaire

    1 month

  • The cost of each treatment

    1 hour

  • The necessity to use rescue therapy

    30 minutes

  • Side effects of each treatment

    30 minutes

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

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

Drug: Morphine

Morphine

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

KetorolacDRUG

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

Morphine
MorphineDRUG

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

Ketorolac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of musculoskeletal low back pain
  • grade 5 pain on a 1-10 visual pain scale

You may not qualify if:

  • contraindications of ketorolac or opioids
  • pregnancy
  • known allergies to ketorolac or opioids
  • post-traumatic low back pain
  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

KetorolacMorphine

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Dan Marinescu, MD

    Clinical Emergency Hospital Bucharest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Marinescu, MD

CONTACT

0040741020848danvmarinescu@gmail.com

Vlad A Maltezeanu, MD

CONTACT

0040720943180vladmaltezeanu@yahoo.co.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 25, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-05