Pain, Postoperative Clinical Trial
Official title:
A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Dilatation of the cervix is necessary before operative hysteroscopic procedures. This
dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical
priming with various substances soften the cervix, ease the entry for the operation and
decrease complications such as uterine perforation.
The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl
bromide" with sham protocol.
The study is planned as a double blind randomised controlled one centre study. It will take
part at a operative gynaecological department of a university hospital. Women who apply to
the university clinic who have a medical indication for hysteroscopic surgery will be
recruited after informed consent.
Patients included in the study will be allocated to three groups. The intervention arms will
be two arms and one sham group. The randomisation will be performed to three groups by a
third party who is not involved in the surgical procedures.
Upon initial evaluation, a form evaluating age and other sociodemographic characteristics
will be filled out before the scheduled hysteroscopy procedure. After completion of the
initial form, rectal tablets will be administered according to the allocated group; two hours
previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm
hysteroscope during the follicular phase of the menstrual cycle.
During the procedure the duration of the cervical entry and total duration of the operation
will be noted. Additionally basal dilatation will be noted.
Two hours after the procedure pain will be documented according to the Visual Analogue Scale
which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates
"excruciating" pain.
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