Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Study Overview
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Brief Summary
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The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.

Detailed Description
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This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU]. Patients fulfilling inclusion and exclusion criteria will be divided into three groups. Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure. Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure. Group C (control group) Include 34 patients who will receive a placebo. Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Official Title
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Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial

Conditions
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Pain, Procedure

Intervention / Treatment
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* Drug: Tramadol
* Drug: Diclofenac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI raging between (18.5 - 30 ). Scheduled for diagnostic hysteroscopy only. All of them should have given informed written consent. Exclusion Criteria: Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection). Receiving any other form of analgesia. Patients with known cervical stenosis, polyps and ulcers. Previous cervical surgery. Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy. known sensitivity to non-steroidal anti-inflammatory and opioids drugs. Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction. Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br>Women will receive oral tramadol 100 mg 1 hour before the procedure | Drug: Tramadol<br>* Women will receive a oral Tramadol 100mg 1 hour before the procedure<br>|
| Active Comparator: Diclofenac<br>Women will receive 100 mg diclofenac 1 hour before the procedure | Drug: Diclofenac<br>* Women will receive oral Diclofenac 100mg 1 hour before the procedure<br>|
| Placebo Comparator: Placebo<br>Women will receive a placebo 1 hour before the procedure | Drug: Placebo<br>* Women will receive a Placebo 1 hour before the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure | Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy | intraoperative | 
| pain after the procedure | 15 minutes after procedure using a 100mm line visual analog scale | 15 minutes after completing the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect and difficulties | Recorded in Case Record Form | 24 hours |