Efficacy of orally administered Tramadol in reducing pain associated with hysteroscopic procedure

Efficacy and safety of Oral Tramadol in Outpatient Vaginoscopic Hysteroscopy: A Double blinded Randomized Placebo Controlled trial - TIPSY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007394

Enrollment

100

Registered

2016-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ABNORMAL UTERINE BLEEDING

Interventions

Intervention1: GROUP A: ORAL TRAMADOL 50 MG ADMINISTERED 1 HOUR BEFORE HYSTEROSCOPY PROCEDURE Control Intervention1: GROUP B: PLACEBO ADMINISTERED 1 HOUR BEFORE HYSTEROSCOPY PROCEDURE

Eligibility

Inclusion criteria

Inclusion criteria: ALL WOMEN OF REPRODUCTIVE AGE GROUP UNDERGOING DIAGNOSTIC HYSTEROSCOPY

Exclusion criteria

Exclusion criteria: KNOWN ALLERGY TO TRAMADOL / OPIOIDS CARDIAC OR RESPIRATORY DISEASE KNOWN CASE OF LIVER OR KIDNEY DISEASE KNOWN CASE OF EPILEPSY NEUROLOGICAL/PSYCHIATRIC DISORDERS THAT AFFECT EVALUATION OF PAIN

Design outcomes

Primary

Measure	Time frame
PAIN PERCEPTION USING VISUAL ANALOGUE SCALETimepoint: DURING HYSTEROSCOPY PROCEDURE IMMEDIATELY AFTER PROCEDURE 30 MINUTES AFTER PROCEDURE	—

Secondary

Measure	Time frame
1)PROCEDURAL TIME- DEFINED AS TIME FROM INTRODUCTION OF HYSTEROSCOPE INTO EXTERNAL CERVICAL OS TO VISUALIZATION OF UTERINE CAVITY 2)EASE OF ENTRYTimepoint: DURING HYSTEROSCOPY PROCEDURE IMMEDIATELY AFTER PROCEDURE 30 MINUTES AFTER PROCEDURE	—

Countries

India

Contacts

Public ContactDR DILIP KUMAR MAURYA

JIPMER

dilipkumar.m@jipmer.edu.in9442136037

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026