- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318187
Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain
Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey
- Pamukkale University
-
Denizli, Turkey, 20020
- Pamukkale University Hospital Emergency Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Morphine
|
1 gr
Other Names:
0.1mg/kg intravenous in 100 ml serum physiologic
Other Names:
|
Experimental: Paracetamol
|
1 gr
Other Names:
0.1mg/kg intravenous in 100 ml serum physiologic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes interval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events.
Time Frame: 30th minutes after
|
30th minutes after the study drug administered
|
30th minutes after
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mustafa Serinken, Proffesor, Pamukkale University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- serinken 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urolithiasis
-
Singapore General HospitalUnknown
-
University of Sao Paulo General HospitalCompletedUrolithiasis and Aging | Renal Calcul and Metabolic Diseases | Urolithiasis and OsteoporosisBrazil
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingKidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingHealthy | Kidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
EULIS Colloborative Research Working GroupUnknownKidney Calculi | Nephrolithiasis | Patient Compliance | Calcium Oxalate Urolithiasis
-
Catalysis SLCompletedKidney Calculi | Kidney Injury | Urolithiasis | Ureteral Calculi | Ureteral Obstruction | Renal Disease | Renal Stone | Ureteral Injury | Renal Injury | Urolithiasis, Calcium Oxalate | Urolithiasis; Lower Urinary TractNicaragua
-
University of Alabama at BirminghamActive, not recruitingCalcium Oxalate UrolithiasisUnited States
-
Lawson Health Research InstituteSt. Joseph's Health Care LondonActive, not recruitingKidney Calculi | Nephrolithiasis | Kidney Stone | Human | Calcium Oxalate Urolithiasis | Vitamin K 2 | Calcium Oxalate Kidney Stones | Calcium Phosphate UrolithiasisCanada
-
United States Naval Medical Center, San DiegoUnknownKidney Stones, Urolithiasis, Hypocitraturia
-
Catalysis SLCompletedRecurrent Calcic UrolithiasisCuba
Clinical Trials on paracetamol
-
GlaxoSmithKlineCompleted
-
University of HelsinkiFoundation for Paediatric Research, FinlandCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedHealthy SubjectsUnited States
-
Kamuzu University of Health SciencesCompleted
-
Baxter Healthcare CorporationCompletedPain, PostoperativeUnited Kingdom
-
GlaxoSmithKlineCompleted
-
Universitaire Ziekenhuizen KU LeuvenCompleted