NCT04762147|CompletedPhase 3DMC
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Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
October 2016
Actual (reported)Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2016
Actual (reported)June 2017
Actual (reported)June 2017
Actual (reported)February 2, 2021
Actual (reported)February 21, 2021
Actual (reported)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
Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery
Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
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.
Dileep Kumar, FCPS
Aga Khan University
60 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2021
First Posted
February 21, 2021
Study Start
October 2016
Actual (reported)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
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Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
February 21, 2021
Record last verified: 2021-02
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