Comparative Evaluation of oral Melatonin and Pregabalin as premedicants for perioperative anxiety and post operative pain in daycare surgeries-A Randomized control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To check for effective analgesia between study groups using Visual Analogue Score(VAS)
Study Overview
Brief Summary
After getting approval from ethical committee, Patients posted for daycare surgeries will be taken up for study after obtaining written and informed consent. Pre-anaesthetic checkup will be done and those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study. Patients will be randomized into two groups, the Melatonin group and the Pregabalin group. Melatonin group patients will receive 3mg of Tab. Melatonin 6 hours before surgery. The other group will be given Tab. Pregabalin 75mg 6 hours before surgery. Patient will be kept NPO 8 hours before surgery. VAS, Anxiety Score and Sedation score will be noted at the time intervals from the beginning of premedication 4th hourly.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age: 18 years to 60 years
- •Patients undergoing daycare surgeries
- •Both Sex 4.
Exclusion Criteria
- •Not willing
- •Patient on long term analgesics and opioid containing drugs
- •Allergy to those medications
- •Pregnant and lactating women.
Outcomes
Primary Outcomes
To check for effective analgesia between study groups using Visual Analogue Score(VAS)
Time Frame: baseline, 4th hour, 8th hour
Secondary Outcomes
- To evaluate anxiety relieving effect and sedation between two groups using Beck Anxiety Inventory Scale and Observer Assessment Alertness Scale(baseline, 4th hour, 8th hour)
Investigators
Reeya Mathew
Shri Sathya Sai Medical College and Research Institute