Clinical Trials Logo

Clinical Trial Summary

Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). The colicky-type pain in the ureter, an increase in proximal peristalsis through activation of intrinsic ureteral pacemakers may contribute to the perception of pain. Muscle spasm increased proximal peristalsis, local inflammation, irritation, and oedema at the site of obstruction may contribute to the development of pain through chemoreceptor activation and stretching of submucosal free nerve endings. α-adrenergic blockers, anti-inflammatory drugs, antihistaminic and calcium channel blockers, which have a relaxant effect on the ureteric smooth musculature. The presence of histamine receptors in the ureter have been presented in various studies. The histamine-1 (H1) receptors have been shown to have a wide distribution Histamine, which is secreted from the mast cells, causes strong peristaltic contractions in the ureter. alpha adrenoreceptor antagonists (i.e., tamsulosin) have been employed in the treatment of ureteric colic due to smooth muscle relaxation so their potential ability to increase stone passage, reduce pain medication use and reduce urologic interventions. According to the currently accepted view, renal colic management starts with NSAI drugs also NSAI has role in decrease inflammation and oedema and increase expulsion rate . in this study we will compare the use of alpha blocker versus alpha blocker and antihistaminic in management of acute renal colic prevent pain recurrence and increase expulsion rate of ureteric stone ≤ 1cm, with analgesic use in case of acute stage.


Clinical Trial Description

All the patients will be included within inclusion criteria After providing written informed consent, these patients were randomly divided into 2 groups by use of a computer-generated random number table. 1. history taken about patient pain onset, duration and type with scoring the pain by World Health Organization numerical pain score of 0-10. 2. Ultrasonography done to determine if kidney obstructed and grade of obstruction at the day 1 day 15 and day 30. 3. group A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand, group B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand. 4. In case of patient presented by acute renal colic the time of administration of treatment recorded and the time of relief pain recorded. 5. CT scan done to ensure urolithiases if no CT done at the first day and after 30 days. 6. Full labs done especially serum creatinine and serum uric acid. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05150899
Study type Observational [Patient Registry]
Source Assiut University
Contact adel kurkar, MD
Phone 01098197880
Email adel.abdelmouteleb@med.aun.edu.eg
Status Not yet recruiting
Phase
Start date November 30, 2021
Completion date November 25, 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT01685658 - Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations Phase 4
Completed NCT01349244 - Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic N/A
Recruiting NCT04169555 - "Point of Care" Ultrasound and Renal Colic N/A
Completed NCT04160520 - Pramipexole and Morphine for Renal Colic Phase 1/Phase 2
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT03865004 - Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment Phase 4
Completed NCT03638921 - 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER Phase 2
Completed NCT03706404 - Renal Colic Fast Track Pathway in the Emergency Department. N/A
Completed NCT03665753 - Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED Early Phase 1
Recruiting NCT03790514 - Heat Wrap for Renal Colic N/A
Completed NCT00646061 - Pain Control in Renal Colic Phase 1
Completed NCT05653401 - Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. Phase 2
Not yet recruiting NCT02782273 - Morphine Versus Ketorolac in Renal Colic Phase 4
Completed NCT01352676 - Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
Not yet recruiting NCT06412900 - Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
Not yet recruiting NCT06342648 - Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic N/A
Recruiting NCT03137498 - Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department Phase 4
Recruiting NCT01742689 - Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic Phase 3
Completed NCT01546701 - Buprenorphine in Acute Renal Colic Pain Management Phase 4