Clinical Trial: Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial

Brief 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 Summary:

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 p
Sponsor: Pamukkale University

Current Primary Outcome: Reduction in visual analogue scale [ Time Frame: 15 minutes interval ]

The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events. [ Time Frame: 30th minutes after ]

30th minutes after the study drug administered


Original Secondary Outcome: Same as current

Information By: Pamukkale University

Dates:
Date Received: March 17, 2011
Date Started: January 2011
Date Completion:
Last Updated: March 31, 2011
Last Verified: January 2011