Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment

March 5, 2019 updated by: Akdeniz University

Paracetamol Plus Morphine in ED

This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

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 to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Renal colic patients -

Exclusion Criteria: Not renal colic patients

-

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Paracetamol+Morphine
1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • Parol
Drug: Dexketoprofen plus Morphine
Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
Other Names:
  • Arveles
Drug: Placebo plus Morphine
100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • SF
Active Comparator: Paracetamol
Drug: Paracetamol+Morphine
1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • Parol
Drug: Dexketoprofen plus Morphine
Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
Other Names:
  • Arveles
Drug: Placebo plus Morphine
100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • SF
Active Comparator: Dexketoprofene
Drug: Paracetamol+Morphine
1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • Parol
Drug: Dexketoprofen plus Morphine
Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
Other Names:
  • Arveles
Drug: Placebo plus Morphine
100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
Other Names:
  • SF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain reductions in VAS scores during the 60th and 90th minutes
Time Frame: 60 minutes
60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for rescue analgesic
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

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

Sponsor

Akdeniz University

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 (Actual)

October 17, 2015

Primary Completion (Actual)

October 17, 2016

Study Completion (Actual)

October 17, 2018

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • firatbektas

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe