AnalgesiaPhase 3NCT04762147
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
A Phase 3 study testing paracetamol, the group P and fentanyl, group-F administered as an active comparator in people with Analgesia and Effect of Drug, run by Aga Khan University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Effect of Drug
- What is being tested?
- paracetamol, the group P and fentanyl, group-F administered as an active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery
- American Society of Anaesthesiologists (ASA) grade I \& II
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- paracetamol, the group P, fentanyl, group-F administered as an active comparator
- Keywords
- ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol, the group PDrug
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 comparatorDrug
The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol group-P | Experimental | Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery Receives: Drug: paracetamol, the group P |
| Fentanyl group-F | Active comparator | Fentanyl 2mcg/kg was administered at the time induction of anaesthesia Receives: Drug: fentanyl, group-F administered as an active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 minutes post-anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dileep Kumar, Aga Khan University
- Investigators
- Dileep Kumar, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762147
- Sponsor's protocol ID
- 4370-Ane-ERC-16
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD data will be shared through the publication but without the sharing the participants identities.
Publications
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.
PubMed 25788774
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
- ClinicalTrials.gov ID
- NCT04762147
- Acronym / sponsor ID
- 4370-Ane-ERC-16
- Conditions
- Analgesia, Effect of Drug
- Keywords
- ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol group-P | Experimental | Drug: paracetamol, the group PParacetamol 15mg/Kg was dministered 30 minutes before the start of surgery |
| Fentanyl group-F | Active comparator | Drug: fentanyl, group-F administered as an active comparatorFentanyl 2mcg/kg was administered at the time induction of anaesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgery
- American Society of Anaesthesiologists (ASA) grade I \& II
Key exclusion criteria (7 listed)
- Patients with anticipated difficult airway
- Gastro-oesophageal reflux disorder
- Body mass index (BMI) >30kg/m2
- Known Hepatic disorder
- Known ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracetamol, the group PThe paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy | Drug | Paracetamol group-P |
| fentanyl, group-F administered as an active comparatorThe fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy | Drug | Fentanyl group-F |
Primary outcome
Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure
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
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
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
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
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
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
Time frame: Immediately post-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
Time frame: 15 minutes post-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
Time frame: 30 minutes post-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 25788774Ali 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.
- Individual participant dataSharing planned: Yes. All IPD data will be shared through the publication but without the sharing the participants identities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep Kumar, FCPS principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paracetamol, the group P and fentanyl, group-F administered as an active comparator in people with Analgesia and Effect of Drug, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04762147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.