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

December 8, 2021 updated by: Mostafa Kamel Abdel Rahman, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tamsulosin 0.4mg
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.
Drug: Tamsulosin Hcl 0.4Mg Cap
alpha blocker
Other Names:
  • tamsule
fexofenadine 180 mg in combination of Tamsulosin 0.4mg
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.
Drug: Tamsulosin Hcl 0.4Mg Cap
alpha blocker
Other Names:
  • tamsule
Drug: fexofenadine 180 mg Oral tablet
antihistaminic
Other Names:
  • telefast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of each treatment in case of patient presented with acute renal colic
Time Frame: 3 weeks
(% of patients show relief of the pain).
3 weeks
Duration of relieve of the symptoms
Time Frame: in 24 hours
relieve of renal colic
in 24 hours
Rate of recurrence of pain and if need analgesic
Time Frame: 3 weeks
how many times pain come again
3 weeks
Numbers of patients showing expulsion of stone
Time Frame: 3 weeks
how many people stone expulsed during treatment
3 weeks
Number of patients underwent URS and duration taken from start of treatment
Time Frame: 3 weeks
patient with persistent pain
3 weeks
Rate of complication from treatment
Time Frame: 3 weeks
any side effect from treatment
3 weeks
Rate of hospital admission and number of admissions.
Time Frame: 3 weeks
due to persistent pain
3 weeks
Rate of drop out from the study due to complication or noncompliance.
Time Frame: 3 weeks
patient exit from study
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: adel kurkar, MD, Assiut University
  • Principal Investigator: mostafa kamel, demonstrator, Assiut University
  • Study Chair: ahmed eltaher, MD, Assiut University
  • Study Chair: ahmed elbadry, MD, Assiut University
  • Study Chair: ahmed abdelhameed, MD, Assiut University
  • Study Chair: rabee gadelkareem, MD, Assiut University
  • Study Chair: hosney behnsawy, MD, Assiut University
  • Study Chair: mohamed zarzour, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 30, 2021

Primary Completion (Anticipated)

November 25, 2022

Study Completion (Anticipated)

November 25, 2022

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • antihistaminic in renal colic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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