Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management

March 17, 2015 updated by: Dr. SAMEER PATHAN, Hamad Medical Corporation

A Double Blind, Multi-arm Randomized Control Trial, for Efficacy of Intramuscular Diclofenac Versus Intravenous Morphine Versus Intravenous Paracetamol, in Renal Colic Emergency Department Pain Management

Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and to be pain free as early as possible. There are variations in physician preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:

  • Opioids such as Morphine or Fentanyl
  • Non steroidal drugs such as Diclofenac, Ketorolac or Brufen
  • and Paracetamol intravenous injection.

A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking. This study is design to obtain data on efficacy of these three drugs within 30 minutes in a non inferiority trail.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a double blind RCT, where participants will be enrolled consecutively after meeting eligibility criteria and obtaining a written informed consent. They will be assign to one of the three study arms by computer generated randomization process. The study packets will be prepared by a dedicated nurse or pharmacist who will not a part of investigating team. Each Patients will receive one analgesic drug (active drug) and two placebos. Drugs will be given as one intramuscular injection and two intravenous solutions.

Pain score will be recorded using NRS at 0, 30, 60, and 90 minutes. Data will be collected on standard Data collection form. Each participant will receive analgesia from study packet which contains, one active drug and two placebos to be administer as one intramuscular and two intravenous solutions. At any given time every patient will receive one analgesia from either Diclofenac, Paracetamol or Morphine. If patient pain does not respond to initial treatments, at 30 minutes a rescue analgesia in form of morphine will be administered till patient is pain free or NRS<=2 or adverse event to morphine.

Based on the results of previous studies (1-3), proportion of patients achieving more than 50% pain reduction, is between 65-75% for diclofenac, morphine and paracetamol when compared with other drugs. In each group, 437 patients are required to detect a difference of 10% in primary outcome, in a superiority trial with power (1-beta) of 90% and significance level (alpha) of 5% in this study. Considering 15% extra, total sample size required in this superiority trial will be 1507 patients in total.

Data will be collected on a standard data recording form and it will be converted to electronic excel sheet hiding patient identifiable details. Continuous variables will be presented as mean with standard deviation (SD). Categorical variables will be calculated as proportions and presented with 95% Confidence interval (CI). Statistical analyses will be undertaken using Stata 12.0 (College Station, Texas).

Study Type

Interventional

Enrollment (Actual)

1645

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Emergency Department, Hamad General Hospital.

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >=18 years and < 65 years
  • Acute onset, one side flank or loin pain, with or without radiation to groin or genital areas.
  • Pain intensity on NRS more than or equal to 4. (Moderate to Severe Pain)
  • Diagnosis confirmed by non contrast CT KUB within the ED visit.

Exclusion Criteria:

  • Traumatic flank pain
  • Pregnancy
  • Known renal failure or impairment
  • Known allergy to morphine, diclofenac or paracetamol
  • Bronchial asthma
  • Previously enrolled in the study.
  • Use of any analgesia in last 6 hour.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diclofenac and Placebos
Participants in this group will receive a Diclofenac 75 mg intramuscular injection, and two placebo saline solutions intravenously.
Drug: Diclofenac
Other Names:
  • Voltaren
  • Diclofen
  • Diclorex
Drug: Placebos
Other Names:
  • saline solution
ACTIVE_COMPARATOR: Morphine and Placebos
Participants in this group will receive Morphine 0.1 mg/kg intravenously, along with an additional intravenous placebo and an intramuscular placebo injection.
Drug: Morphine
Other Names:
  • Morphine sulphate
Drug: Placebos
Other Names:
  • saline solution
ACTIVE_COMPARATOR: Paracetamol and Placebos
participants in this group will receive intravenous Paracetamol 1 gm solution, along with an additional intravenous placebo and an intramuscular placebo injection.
Drug: Paracetamol
Other Names:
  • Perfalgan
  • Acetaminophen
Drug: Placebos
Other Names:
  • saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm.
Time Frame: at 30 minutes after analgesia
at 30 minutes after analgesia

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction in mean NRS
Time Frame: at 30, 60 and 90 minutes after analgesia
at 30, 60 and 90 minutes after analgesia

Other Outcome Measures

Outcome Measure
Time Frame
adverse event rate
Time Frame: Within 14 days of ED visit
Within 14 days of ED visit
total analgesia requirement to get pain score (NRS) less than or equal to 2.
Time Frame: by 90 minutes
by 90 minutes

Collaborators and Investigators

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

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Dr.Sameer A. Pathan, MBBS, MCEM, Hamad Medical Corporation
  • Principal Investigator: Prof. Peter A Cameron, MD,FACEM, Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (ESTIMATE)

July 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB Number: 14-00059
  • Hamad Medical Corporation-MRC (OTHER_GRANT: IRGC-01-NI-045)

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.

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