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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol group-P | Experimental | Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery |
|
| Fentanyl group-F | Active Comparator | Fentanyl 2mcg/kg was administered at the time induction of anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Hysteroscopy is procedure perfomed in females only
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| Name | Affiliation | Role |
|---|---|---|
| Dileep Kumar, FCPS | Aga Khan University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25788774 | Background | 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. |
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All IPD data will be shared through the publication but without the sharing the participants identities.
After recruitment of sample size
The data can be accessed by requesting the institutional ethical review committee and falling under the category of data sharing
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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 |
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |