NCT04762147

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Analgesia
• Effect of Drug

Interventions

Type	Name	Description
DRUG	paracetamol, the group P	The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
DRUG	fentanyl, group-F administered as an active comparator	The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2021-02-21
• Last updated: 2021-02-21