NCT01465984

Brief Summary

The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

November 2, 2011

Last Update Submit

December 6, 2012

Conditions

Acute Pain

Keywords

ParacetamolMorphine sulfatesAcute pain

Outcome Measures

Primary Outcomes (1)

  • Change in pain severity/score

    after 30 minutes

Secondary Outcomes (1)

  • Need for rescue analgesia

    After 30 minutes

Study Arms (2)

IV Paracetamol

EXPERIMENTAL
Drug: Paracetamol

IV Morphine Sulfate

ACTIVE COMPARATOR
Drug: Paracetamol

Interventions

ParacetamolDRUG

paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv

IV Morphine SulfateIV Paracetamol

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of acute limb trauma
  • Age\>=18 years
  • Acute pain of score 3 or greater on visual analogue scale

You may not qualify if:

  • Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
  • Known sensitivity to opioids or paracetamol
  • Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
  • Previous administration of analgesic during 6 hours ago
  • Pregnant women
  • diagnosed heart failure
  • renal failure
  • pulmonary failure or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUMS

Tehran, Tehran Province, 1417613151, Iran

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohammad Jalili, MD

    TUMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 7, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

IR(1)