NCT05150899

Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm

Comparative Study Between 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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Renal Colic
• Ureter Stone

Interventions

Type	Name	Description
DRUG	Tamsulosin Hcl 0.4Mg Cap	alpha blocker
DRUG	fexofenadine 180 mg Oral tablet	antihistaminic

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-11-25
• Completion: 2022-11-25
• First posted: 2021-12-09
• Last updated: 2021-12-09

Regulatory

• FDA-regulated drug study