Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
Primary Purpose
Analgesia, Effect of Drug
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
paracetamol, the group P
fentanyl, group-F administered as an active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paracetamol group-P
Fentanyl group-F
Arm Description
Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery
Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04762147
First Posted
February 2, 2021
Last Updated
February 18, 2021
Sponsor
Aga Khan University
1. Study Identification
Unique Protocol Identification Number
NCT04762147
Brief Title
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
Official Title
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Effect of Drug
Keywords
ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol group-P
Arm Type
Experimental
Arm Description
Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery
Arm Title
Fentanyl group-F
Arm Type
Active Comparator
Arm Description
Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
Intervention Type
Drug
Intervention Name(s)
paracetamol, the group P
Intervention Description
The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
Intervention Type
Drug
Intervention Name(s)
fentanyl, group-F administered as an active comparator
Intervention Description
The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
Primary Outcome Measure Information:
Title
Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure
Description
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
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
Title
Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure
Description
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
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
Title
Intra-operative pain assessment was based on changes in each five minutes interval in heart rate
Description
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
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
Title
Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia
Description
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
Time Frame
Immediately post-anaesthesia
Title
Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia
Description
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
Time Frame
15 minutes post-anaesthesia
Title
Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia
Description
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
Time Frame
30 minutes post-anaesthesia
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Hysteroscopy is procedure perfomed in females only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dileep Kumar, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD data will be shared through the publication but without the sharing the participants identities.
IPD Sharing Time Frame
After recruitment of sample size
IPD Sharing Access Criteria
The data can be accessed by requesting the institutional ethical review committee and falling under the category of data sharing
Citations:
PubMed Identifier
25788774
Citation
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.
Results Reference
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Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
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