Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Endoscopy

Treatments: Drug: hyoscine butyl bromide; Drug: placebo; Drug: diclofenac potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT02714699

HB-OH

Details and patient eligibility

About

The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy

Enrollment: 129 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
5. Absence of sedative use before admission

Exclusion criteria

1. Hypersensitivity to drugs
2. refusal of the patient
3. Patients are pregnant.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 3 patient groups, including a placebo group

diclofenac potassium

Experimental group

Description:

oral diclofenac potassium

Treatment:

Drug: diclofenac potassium

hyoscine butyl bromide

Active Comparator group

Description:

oral hyoscine butyl bromide

Treatment:

Drug: hyoscine butyl bromide

placebo

Placebo Comparator group

Description:

oral placebo

Treatment:

Drug: placebo