Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain

NCT ID: NCT01318187

Last Updated: 2011-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-03-31

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 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.

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paracetamol

Group Type: EXPERIMENTAL

paracetamol

Intervention Type: DRUG

1 gr

morphine

Intervention Type: DRUG

0.1mg/kg intravenous in 100 ml serum physiologic

Paracetamol

Intervention Type: DRUG

1 gr intravenous

Paracetamol

Intervention Type: DRUG

intravenous 1 gr

Morphine

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

1 gr

morphine

Intervention Type: DRUG

0.1mg/kg intravenous in 100 ml serum physiologic

Morphine

Intervention Type: DRUG

0.1 mg/kg intravenous

Interventions

paracetamol

1 gr

Intervention Type: DRUG

morphine

0.1mg/kg intravenous in 100 ml serum physiologic

Intervention Type: DRUG

Paracetamol

1 gr intravenous

Intervention Type: DRUG

Paracetamol

intravenous 1 gr

Intervention Type: DRUG

Morphine

0.1 mg/kg intravenous

Intervention Type: DRUG

Other Intervention Names

Perfalgan; Morphine CHL 0.01 gr; Perfalgan; Perfalgan

Eligibility Criteria

Inclusion Criteria

Adults (aged 16 to 55 years old) with acute low back pain were eligible for inclusion in the study

Exclusion Criteria

• known allergy or contraindication to morphine, paracetamol, or any opioid analgesic
• hemodynamic instability; fever (temperature > 38°C [100.4°F])
• evidence of peritoneal inflammation
• documented or suspected pregnancy
• known or suspected aortic dissection or aneurysm
• use of any analgesic within 6 hours of ED presentation
• previous study enrollment Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Pamukkale University

Principal Investigators

Mustafa Serinken, Proffesor

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Pamukkale University Hospital Emergency Department

Denizli, , Turkey (Türkiye)

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Bektas F, Eken C, Karadeniz O, Goksu E, Cubuk M, Cete Y. Intravenous paracetamol or morphine for the treatment of renal colic: a randomized, placebo-controlled trial. Ann Emerg Med. 2009 Oct;54(4):568-74. doi: 10.1016/j.annemergmed.2009.06.501. Epub 2009 Jul 31.

Reference Type: RESULT

PMID: 19647342 (View on PubMed)

Serinken M, Eken C, Turkcuer I, Elicabuk H, Uyanik E, Schultz CH. Intravenous paracetamol versus morphine for renal colic in the emergency department: a randomised double-blind controlled trial. Emerg Med J. 2012 Nov;29(11):902-5. doi: 10.1136/emermed-2011-200165. Epub 2011 Dec 20.

Reference Type: DERIVED

PMID: 22186009 (View on PubMed)

Other Identifiers

serinken 001

Identifier Type: -

Identifier Source: org_study_id