Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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

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Analgesia Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paracetamol group-P

Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery

Group Type EXPERIMENTAL

paracetamol, the group P

Intervention Type DRUG

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

Fentanyl 2mcg/kg was administered at the time induction of anaesthesia

Group Type ACTIVE_COMPARATOR

fentanyl, group-F administered as an active comparator

Intervention Type 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

Interventions

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paracetamol, 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

Intervention Type DRUG

fentanyl, 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes