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

NCT04762147 | Completed Phase 3 DMC

• 1 other identifier: 4370-Ane-ERC-16
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Analgesia; Effect of Drug

Keywords

ParacetamolGeneral anaesthesia; Fentanyl; General Anaesthesia; Hysterescopy

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Paracetamol group-P

EXPERIMENTAL

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

Drug: paracetamol, the group P

Fentanyl group-F

ACTIVE COMPARATOR

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

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

Interventions

paracetamol, the group P DRUG

The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy

Paracetamol group-P

fentanyl, group-F administered as an active comparator DRUG

The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy

Fentanyl group-F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Hysteroscopy is procedure perfomed in females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Related 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.

  PMID: 25788774 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dileep Kumar, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After recruitment of sample size
• Access Criteria: The data can be accessed by requesting the institutional ethical review committee and falling under the category of data sharing