Analgesia, Effect of Drug
Conditions
Keywords
ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy
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.
Interventions
DRUGparacetamol, the group P
The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
DRUGfentanyl, group-F administered as an active comparator
The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure | 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 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 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 | 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 | 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 | 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 |
Outcome results
None listed