Hyoscine Butyl Bromide in Reducing Pain During HSG (HBTB-DIC)

Assiut University

Status and phase: Completed; Phase 4

Conditions: Pain Relief With HSG

Treatments: Drug: placebo; Drug: hyoscine butyl bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02709603

HS2

Details and patient eligibility

About

Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The infertile women who indicated for HSG.

Exclusion criteria

• contraindications to Hyoscine or NSAID - known sensitivity to these drugs
• known sensitivity to contrast media
• abnormal uterine bleeding
• genital tract infection
• suspected pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Treatment:

Drug: hyoscine butyl bromide

Group B

Placebo Comparator group

Description:

oral 2 tablets (PLACEBO) 30 minutes before the procedure

Treatment:

Drug: placebo