A Randomized Double Blinded Placebo-controlled Trial to Compare the Effect of Hyoscine-N-butyl Bromide (HBB) or Celecoxib Administered Alone Versus in Combination to Reduce Pain in Patients Undergoing Office Hysteroscopy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 180
- Primary Endpoint
- Pain during whole procedure
Study Overview
Brief Summary
The aim of this study is to compare the effectiveness and the side effects of hyosine-N- butylbromide (HBB) & Celecoxib administered alone versus in combination reducing pain associated with outpatient hysteroscopy in married female patients aged 18-40 attending the outpatient hysteroscopy clinic of Kasr Al Ainy, Cairo University Hospital.
Detailed Description
This study will be a prospective single centre study that shall include 180 women aged 18-40 years from the outpatient hysteroscopy clinic, Kasr Al Ainy Cairo University Hospitals. After a self-introduction, each patient will be explained thoroughly about what the study is all about and its objective. All patients will be subjected to history taking (specially to rule out an contraindications of HBB & Celecoxib), pelvic examination and TVUS.
We will make sure that each of the patients voluntarily agrees to participate in this study for this, we will request each patient to sign a written consent form. She will be told that she can withdraw from the study any time.
Patient will be randomized into 3 groups using 1:1:1 allocation ratio. An independent person will generate the allocation sequence using computer- generated random numbers. Allocation will be concealed using sequentially numbered (1-180) opaque sealed envelopes kept with the attending nurse and enclosing a paper denoting group A, B or C. The sealed envelopes will be kept with the attending nurse.
After the patients signs their written consent, the nurse will pick a random number from the available allocation sequence and will open the envelop to detect to which allocated group the patient should be allocated to without showing it to the patient or the observer. The drugs will be stored in the outpatient clinic pharmacy under tags A, B or C and the patient will be given the drug with a glass of water. Neither the patient nor the physician will be aware of the drug used. All patients will receive the enclosed medication 1 hour before procedure.
We will divide the patients into three groups according to the medication will receive.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double blinded placebo-controlled
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi, septae)
- •Reproductive age 20 - 40yrs.
- •Postmenstrual days from D-6 to D-11 of the cycle (except in irregular bleeding)
Exclusion Criteria
- •Menopausal and amenorrheic patients
- •Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
- •Previous cervical surgery eg; cauterization and conization
- •Patients whose vaginoscopic approach will not be enough and where a tenaculum will be used.
- •Patients with peptic ulcers or other contraindications to HBB or celecoxib.
- •Patients who will have an office operative procedure will be excluded.
- •Patients who will refuse or ask to be excluded from the study after enrollment.
Arms & Interventions
Group A
(60 participants) will receive two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim) and one capsule of Celecoxib 200 mg (Celebrex 200, Pfizer, USA) simultaneously.
Intervention: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet (Drug)
Group B
(60 participants) will receive one oral placebo capsule similar in size, structure, and color to celecoxib and two oral tablets of HBB (Buscopan 10 mg, Boehringer Ingelheim)
Intervention: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet (Drug)
Group C
(60 participants) will receive two oral placebo tablets similar in size and color to Buscopan tablet and one capsule of Celecoxib 200 mg (Celebrex ® 200, Pfizer, USA).
Intervention: Celecoxib 200 mg, Hyoscine-N-butyl bromide (HBB), placebo tablet (Drug)
Outcomes
Primary Outcomes
Pain during whole procedure
Time Frame: 1 hour
The pain sensation during the procedure. The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
Secondary Outcomes
- Post procedural pain(1 hour)
Investigators
Senderila Abdulkareem
Dr.
Cairo University