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Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management

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ClinicalTrials.gov Identifier: NCT02187614
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. SAMEER PATHAN, Hamad Medical Corporation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Renal Colic Urinary Calculi Drug: Diclofenac Drug: Morphine Drug: Paracetamol Drug: Placebos Phase 4

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  (Clinical Trial)
Actual Enrollment : 1645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Morphine sulphate
Drug: Placebos
Other Name: 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 Name: saline solution



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. reduction in mean NRS [ Time Frame: at 30, 60 and 90 minutes after analgesia ]

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187614


Locations
Qatar
Emergency Department, Hamad General Hospital.
Doha, Qatar, 3050
Sponsors and Collaborators
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. SAMEER PATHAN, Research Fellow and Specialist, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02187614     History of Changes
Other Study ID Numbers: IRB Number: 14-00059
Hamad Medical Corporation-MRC ( Other Grant/Funding Number: IRGC-01-NI-045 )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Dr. SAMEER PATHAN, Hamad Medical Corporation:
Acute Renal colic
Acute Ureteric Colic
Renal or Ureteral Calculi
Urolithiasis
Kidney or Ureteral stones

Additional relevant MeSH terms:
Colic
Calculi
Renal Colic
Urinary Calculi
Infant, Newborn, Diseases
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urolithiasis
Urologic Diseases
Pharmaceutical Solutions
Morphine
Acetaminophen
Diclofenac
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors