Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management
Condition: Renal Colic; Urinary Calculi
MeSH terms: Urinary Calculi; Urolithiasis; Colic; Calculi; Renal Colic
Study type: Interventional
Phase: Phase 4

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.
    

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).
    

Intervention name(s): Diclofenac; Morphine; Paracetamol; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Voltaren; Diclofen; Diclorex; Morphine sulphate; Perfalgan; Acetaminophen; saline solution
Intervention MeSH terms: Acetaminophen; Diclofenac; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Renal colic; Acute Ureteric Colic; Renal or Ureteral Calculi; Urolithiasis; Kidney or Ureteral stones