Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

Last updated: February 18, 2021
Sponsor: Aga Khan University
Overall Status: Completed

Phase

3

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT04762147
4370-Ane-ERC-16
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

Objective of study:

To compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy.

Hypothesis of study:

There is no difference in pain control between intravenous fentanyl and paracetamol in patients undergoing hysteroscopy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Elective surgery
  • American Society of Anaesthesiologists (ASA) grade I & II

Exclusion

Exclusion Criteria:

  • Patients with anticipated difficult airway
  • Gastro-oesophageal reflux disorder
  • Body mass index (BMI) >30kg/m2
  • Known Hepatic disorder
  • Known ischemic heart disease
  • History of hypersensitivity reactions to paracetamol and fentanyl or already takingparacetamol and fentanyl
  • Patient experiencing the iatrogenic intra-operative uterine perforation

Study Design

Total Participants: 60
Study Start date:
October 01, 2016
Estimated Completion Date:
June 30, 2017

Study Description

Intraoperative pain assessment will be based on:

Hemodynamic vital (SBP, DBP. MAP and HR) increase 20% from the baseline will be observed and assumed pain.

Postoperative pain assessment will be based on:

Mean Pain score :Visual analogue pain scale (VAS) of 0-10 cms will be used to assess the pain at the end of the procedure.

Diagnostic hysteroscopy:

Patients presenting with abnormal premenopausal or postmenopausal uterine bleeding, pain, infertility, intrauterine adhesions, endometrial biopsy, foreign body.

Therapeutic hysteroscopy:

To remove IUD, uterine polyps, fibroid, foreign body and submucosal fibroids, sterilization.