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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762147
• Other study ID #: 4370-Ane-ERC-16
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Effect of Drug

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

References & Publications (1)

Ali MA, Shamim F, Chughtai S. Comparison between intravenous paracetamol and fentanyl for intraoperative and postoperative pain relief in dilatation and evacuation: Prospective, randomized interventional trial. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):54-8. doi: 10.4103/0970-9185.150542. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure	To assess the intra-operative pain by changes in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain	Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
Primary	Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure	To assess the intra-operative pain by changes in hemodynamic parameters such as mean arterial blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain	Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
Primary	Intra-operative pain assessment was based on changes in each five minutes interval in heart rate	To assess the intra-operative pain by changes in hemodynamic parameters such as heart rate rising from the 20 percent of the baseline value were considered that the patient is experiencing pain	Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
Primary	Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia	To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit.; Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10	Immediately post-anaesthesia
Primary	Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia	To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit.; Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10	15 minutes post-anaesthesia
Primary	Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia	To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit.; Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10	30 minutes post-anaesthesia