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Hyoscine Butyl Bromide in Reducing Pain During HSG

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02709603
Acronym
HBTB-DIC
Enrollment
200
Registered
2016-03-16
Start date
2016-03-31
Completion date
2016-06-30
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief With HSG

Brief summary

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.

Interventions

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

DRUGplacebo

oral placebo; 2 tablets 30 minutes before the procedure

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean pain score during. hysterosalpingography by visual analog scaleintraoperative

Secondary

MeasureTime frame
Mean pain score after hysterosalpingography30 minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026