Study of Pain Control in Diagnostic Hysteroscopy

The Efficacy of Combination of Ibuprofen and Paracetamol for Pain Control in Diagnostic Hysteroscopy

The goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. The main question it aims to answer is "Do the Paracetamol and Ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Combination product: Ibuprofen-Paracetamol

Detailed Description

After the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get Paracetamol 500mg and Ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in VAS before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao College of Medicine and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old

Exclusion Criteria:

• Women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding
• Women with history of allergy to Paracetamol or Ibuprofen medicine
• Women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding
• Women with currently taking anticoagulant or antiplatelet medications
• Women with history of psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No medication before hysteroscopic procedure
Experimental: Ibuprofen-Paracetamol; Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, before hysteroscopic procedure 30minutes	Combination product: Ibuprofen-Paracetamol; Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain score comparing between study and control group	Comparing the pain score in visual analogue scale of 1(minimum) to 10scores(maximum) which is less to more painful respectively(higher score means more painful and worse outcome)	During and 30minutes after the hysteroscopic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The associated factors effecting the pain of the procedure	Comparing the pain score in visual analogue scale of 1(minimum) to 10scores (maximum) which is less to more painful respectively(higher score means more painful and worse outcome)between the participants with the possible associated factor effecting the pain of the procedure those are history of undergo vaginal delivery, history of undergo the hysteroscopy procedure and post menopause in both control group(no medication) and study group(Paracetamol and Ibuprofen)	During and 30minutes after the hysteroscopic procedure

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: PMK-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No