Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: (OPH)

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Pain, Procedure

Treatments: Drug: Diclofenac; Drug: Tramadol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02760888

EDCU HY

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 3 patient groups, including a placebo group

Tramadol

Active Comparator group

Description:

Women will receive oral tramadol 100 mg 1 hour before the procedure

Treatment:

Drug: Tramadol

Diclofenac

Active Comparator group

Description:

Women will receive 100 mg diclofenac 1 hour before the procedure

Treatment:

Drug: Diclofenac

Placebo

Placebo Comparator group

Description:

Women will receive a placebo 1 hour before the procedure

Treatment:

Drug: Placebo