Clinical trial NCT05150899: Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Colic
Ureter Stone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non-probability sample size) with Confidence Level 90 %, Population Size 10000, Margin of Error 8 % with expected size of 100 patients enrolled in the study. these patients were randomly divided into 2 groups 50 in each group.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age from 14 to 70 years old.
* Patient with ureteric stone 5-10 MM.
* Patient with acute renal colic presented to emergency with obstructed kidney with urgent MSCT show stone ureter 5-10 MM and patient come without colic with CT showing lower third stone of the same measurement.

Exclusion Criteria:

* Age less than 14 or more than 70.
* Chronically diseased patient cardiac that contraindicated to take PD5I or tamsulosin.
* Only functioning kidney.
* CKD Patient.
* Bilateral ureteric stone.
* urinary tract infection.
* severe refractory pain.
* severe hydronephrosis.
* multiple ureteric stones.
* ischemic heart disease, congestive cardiac failure, or complicated hypertension.
* pregnant or lactating mothers.
* patient refuse medical treatment.
* congenital anomalies.
* previous ureteric surgery.

Primary outcomes:
measure: Success rate of each treatment in case of patient presented with acute renal colic
timeFrame: 3 weeks
measure: Duration of relieve of the symptoms
timeFrame: in 24 hours
measure: Rate of recurrence of pain and if need analgesic
timeFrame: 3 weeks
measure: Numbers of patients showing expulsion of stone
timeFrame: 3 weeks
measure: Number of patients underwent URS and duration taken from start of treatment
timeFrame: 3 weeks
measure: Rate of complication from treatment
timeFrame: 3 weeks
measure: Rate of hospital admission and number of admissions.
timeFrame: 3 weeks
measure: Rate of drop out from the study due to complication or noncompliance.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: adel kurkar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: mostafa kamel, demonstrator
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: ahmed eltaher, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: ahmed elbadry, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: ahmed abdelhameed, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: rabee gadelkareem, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: hosney behnsawy, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: mohamed zarzour, MD
role: STUDY_CHAIR
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