Urolithiasis Clinical Trial
Official title:
Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial
Verified date | January 2011 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 73 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University | Denizli | |
Turkey | Pamukkale University Hospital Emergency Department | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Adverse events. | 30th minutes after the study drug administered | 30th minutes after | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04746378 -
PRedictive Accuracy of Initial Stone Burden Evaluation.
|
||
Recruiting |
NCT05100017 -
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
|
N/A | |
Recruiting |
NCT04021381 -
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
|
Phase 3 | |
Completed |
NCT02266381 -
A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
|
N/A | |
Terminated |
NCT01431378 -
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
|
N/A | |
Completed |
NCT01451931 -
Study of Tomography of Nephrolithiasis Evaluation
|
Phase 4 | |
Completed |
NCT02895711 -
Radiation Dose of Pediatric Patients During Ureteroscopy
|
||
Completed |
NCT01295879 -
Vitamin D Repletion in Stone Formers With Hypercalciuria
|
Phase 4 | |
Completed |
NCT05340075 -
Staged Bilateral Percutaneous Nephrolithotomy
|
||
Recruiting |
NCT03919227 -
Measurement of Resistance During UAS Insertion Procedure in RIRS
|
N/A | |
Recruiting |
NCT03717285 -
Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS
|
N/A | |
Completed |
NCT05340088 -
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
|
||
Completed |
NCT05032287 -
Medical Expulsive Therapy Post-SWL For Renal Stones
|
N/A | |
Recruiting |
NCT05701098 -
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
|
N/A | |
Not yet recruiting |
NCT04080973 -
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
|
N/A | |
Terminated |
NCT01736358 -
The Use of Intranasal Ketoralac for Pain Management (Sprix)
|
Phase 4 | |
Completed |
NCT01792765 -
Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
|
N/A | |
Completed |
NCT06211842 -
Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
|
||
Not yet recruiting |
NCT02214836 -
Ultrasound Imaging of Kidney Stones and Lithotripsy
|
N/A | |
Not yet recruiting |
NCT04606758 -
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
|
N/A |