How to Reduce Pain in Patients Undergoing Office Hysteroscopy.

NCT05911126 | Unknown DMC

• 1 other identifier: MD-308-2022
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the effectiveness and the side effects of hyosine-N- butylbromide (HBB) \& Celecoxib administered alone versus in combination reducing pain associated with outpatient hysteroscopy in married female patients aged 18-40 attending the outpatient hysteroscopy clinic of Kasr Al Ainy, Cairo University Hospital.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain during whole procedure

  The pain sensation during the procedure. The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).

  1 hour

Secondary Outcomes (1)

• Post procedural pain

  1 hour

Study Arms (3)

Group A

ACTIVE COMPARATOR

(60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously.

Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet

Group B

ACTIVE COMPARATOR

(60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim)

Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet

Group C

ACTIVE COMPARATOR

(60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA).

Drug: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet

Interventions

Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet DRUG

Tablet form received prior to the procedure

Also known as: (Celebrex ® 200, Pfizer, USA), (Buscopan 10 mg, Boehringer Ingelheim)

Group A; Group B; Group C

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi, septae)
• Reproductive age 20 - 40yrs.
• Postmenstrual days from D-6 to D-11 of the cycle (except in irregular bleeding)

You may not qualify if:

• Menopausal and amenorrheic patients
• Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
• Previous cervical surgery eg; cauterization and conization
• Patients whose vaginoscopic approach will not be enough and where a tenaculum will be used.
• Patients with peptic ulcers or other contraindications to HBB or celecoxib.
• Patients who will have an office operative procedure will be excluded.
• Patients who will refuse or ask to be excluded from the study after enrollment.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain

Interventions

Celecoxib; beta-Globins; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hemoglobin Subunits; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Quaternary Ammonium Compounds; Amines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Eman A Hussein, MD

  Cairo University

  STUDY CHAIR

• Nihal M El-Demiry, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Senderila A Mutlag, MSc

CONTACT

00201099688937; senderila.abdulkareem42687@postgrad.kasralainy.edu.eg

Hisham M Haggag, MD

CONTACT

00201224460134; Hmhaggag@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants will be allocated in 3 groups, first group receiving 2 medications, second group receiving 1 medication and placebo and a third group receiving 1 medication placebo

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 20, 2023
• Study Start: June 13, 2023
• Primary Completion: October 13, 2023
• Study Completion: December 13, 2023
• Last Updated: June 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share