Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain
1 other identifier
interventional
73
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2011
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedApril 1, 2011
January 1, 2011
2 months
March 17, 2011
March 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in visual analogue scale
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
15 minutes interval
Secondary Outcomes (1)
Adverse events.
30th minutes after
Study Arms (2)
Paracetamol
EXPERIMENTALMorphine
ACTIVE COMPARATORInterventions
0.1mg/kg intravenous in 100 ml serum physiologic
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pamukkale University Hospital Emergency Department
Denizli, 20020, Turkey (Türkiye)
Pamukkale University
Denizli, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 19647342RESULTSerinken 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.
PMID: 22186009DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mustafa Serinken, Proffesor
Pamukkale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2011
First Posted
March 18, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 1, 2011
Record last verified: 2011-01