NCT01422291

Brief Summary

This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

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

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 low-back-pain

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

August 22, 2011

Last Update Submit

August 22, 2011

Conditions

Low Back Pain

Keywords

Low back painparacetamoldexketoprofenmorphine

Outcome Measures

Primary Outcomes (1)

  • Reduction in visual analogue scale

    The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered

    15 minutes interval

Secondary Outcomes (1)

  • Adverse events.

    30 minutes after

Study Arms (2)

morphine

ACTIVE COMPARATOR
Drug: Paracetamole

Paracetamole, dexketoprofen

EXPERIMENTAL

Paracetamole, dexketoprofen

Drug: paracetamolDrug: morphineDrug: Dexketoprofen

Interventions

paracetamolDRUG

1 gr

Also known as: Perfalgan
Paracetamole, dexketoprofen
morphineDRUG

0.1mg/kg intravenous in 100 ml serum physiologic

Also known as: Morphine CHL 0.01 gr
Paracetamole, dexketoprofen
DexketoprofenDRUG

50 mg

Also known as: Arveles
Paracetamole, dexketoprofen
ParacetamoleDRUG

1 gr

Also known as: Perfalgan
morphine

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Hemodynamic instability
  • Fever (temperature \>38°C \[100.4°F\])
  • Evidence of peritoneal inflammation
  • Documented or suspected pregnancy
  • Known or suspected aortic dissection or aneurysm, lombar disc hernia
  • Use of any analgesic within 6 hours of ED presentation
  • Previous study enrollment.
  • Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

AcetaminophenMorphinedexketoprofen trometamol

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pamukkale University

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 23, 2011

Record last verified: 2011-08