Pain Relief
Conditions
Brief summary
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
Interventions
DRUGoral hyoscine butyl bromide tablets plus lidocaine cream
patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure
DRUGoral placebo tablets plus placebo cream
patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• The infertile women who indicated for HSG
Exclusion criteria
* contraindications to Hyoscine or lidocaine * known sensitivity to contrast media * abnormal uterine bleeding * genital tract infection * suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean pain score during HSG | intraoperative |
Secondary
| Measure | Time frame |
|---|---|
| Mean pain score after HSG | 30 minutes |
| rate of side effects | 30 minutes |
Countries
Egypt
Outcome results
None listed