Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain
Condition: Urolithiasis
MeSH terms: Urolithiasis; Flank Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and
      safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank
      pain.

      METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial
      comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for patients
      presenting to the emergency department (ED) with acute flank pain. Subjects with inadequate
      pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).
    

Detailed description: 
      Study Design and Setting:

      This is a single-center, prospective, randomized, double-blind, clinical trial performed in
      an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The
      local ethics committee approved the study.

      Two treatment options, intravenous paracetamol and morphine, were compared for ceasing pain
      in patients presented with renal colic.

      Selection of Participants:

      Patients, aged 18 to 55 years, with flank pain were accepted as eligible for the study.
      Patients with clinical diagnosis of acute renal colic and declared to have moderate or
      serious pain according to the 4-point verbal scale were included into the study.

      Exclusion criteria were as follows: patients denied to give inform consent, use of any
      analgesic within six hours of ED presentation, patients with fewer or hemodynamically
      unstable, peritoneal irritation signs, cardiac failure, history of renal and hepatic failure,
      prior known allergy to paracetamol or morphine, suspected or documented pregnancy and
      patients with viewing problems. Patients suspected to have renal colic but ultimately to have
      diagnosis such as renal abscess, renal infarction or renal venous thrombosis were also
      excluded from the study.

      Consecutive patients were enrolled into the study 24 hours a day and seven days a week by the
      senior resident in the shift. The ultimate diagnosis of renal colic was performed by
      displaying the stone either by ultrasonograph (USG) or computerized tomography (CT). USG was
      the first choice for detecting the renal stone. CT was performed if a stone was not detected
      by USG. After CT, patients who were not shown a urolithiasis or pathologies other than renal
      colic were excluded from the study.

      Interventions:

      Study subjects were randomized in order to receive a single dose of either paracetamol
      (Perfalgan, Bristol Myers Squibb, Itxassou, France), 1 gr in 100 ml normal saline, or
      morphine (0.1 mg/kg in 100 ml normal saline) in a blinded fashion. The study drugs was
      written in a paper which is folded four times and covered with sealed bands for allocation
      concealment. The study nurse withdrew one of the drugs from a box. And they were prepared by
      the study nurse and administered by the second nurse blinded to the study. Study drugs were
      identical in color and appearance. Subjects with who needed rescue drug because of inadequate
      pain relief were received fentanyl 1 μg/kg intravenously.

      Methods of Measurements:

      Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain'
      and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe
      pain) just before the drug administration, 15th minutes and 30th minutes after the study drug
      administration. The demographic features of study patients and adverse effects, nausea,
      vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic
      reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry
      mouth, were recorded to the study form.

      Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th
      and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence
      of any adverse event.

      Primary Data Analysis:

      The present study was planned as a superiority trial. When the 20 mm difference in VAS is
      accepted as clinically significant and the standard deviation is accepted as 25 mm, 35
      patients are needed with each group with 95% power. All the analysis were implemented
      according to the intention to treat analysis. The precise of differences between time
      intervals within groups and between groups and statistical significance were expressed by 95%
      confidence intervals (95% CI). All tests of significance were two sided.
    

Intervention name(s): paracetamol; morphine; Paracetamol; Paracetamol; Morphine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 gr; 0.1mg/kg intravenous in 100 ml serum physiologic; 1 gr intravenous; intravenous 1 gr; 0.1 mg/kg intravenous
Other intervention name(s): Perfalgan; Morphine CHL 0.01 gr; Perfalgan; Perfalgan
Intervention MeSH terms: Acetaminophen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: renal colic; paracetamol; morphine; emergency department