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

Aga Khan University

Status and phase: Completed; Phase 3

Conditions: Analgesia; Effect of Drug

Treatments: Drug: paracetamol, the group P; Drug: fentanyl, group-F administered as an active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT04762147

4370-Ane-ERC-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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 taking paracetamol and fentanyl
• Patient experiencing the iatrogenic intra-operative uterine perforation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Paracetamol group-P

Experimental group

Description:

Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery

Treatment:

Drug: paracetamol, the group P

Fentanyl group-F

Active Comparator group

Description:

Fentanyl 2mcg/kg was administered at the time induction of anaesthesia

Treatment:

Drug: fentanyl, group-F administered as an active comparator