Double blinded Randomised Comparative Study of the Effect of Single Preoperative dose of IV Dexmedetomidine vs Fentanyl on the Hemodynamic Stress Responses in Peadiatric patients undergoing Adenotonsillectomy Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY
Study Overview
Brief Summary
In this study we will be giving 2 pain relieving medications namely fentanyl and dexmedetomidine (medication defined by randomisation) to the child before the surgery starts in the holding area. Every child has 50% chance of receiving the drug, depending upon the randomisation. The child will be given a general anaesthesia and will be monitored during the surgery for the effects of these drugs. We will also monitor after the surgery for any restlessness at the end of surgery or later, pain intensity, need for any further drugs to calm the child or pain relief medications.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •AMERICAN SOCIETY OF ANAESTHESIOLOGISTS grades I & II.
- •Aged between 2-10 years of either sex.
Exclusion Criteria
- •Emergency procedures
- •Anticipated difficult airway
- •Presence of neck mass
- •Unstable cardiopulmonary condition
- •Pre-existing laryngeal or tracheal pathology
- •Contraindication to dexmedetomidine
- •History of any recent LRTI
- •Bleeding diathesis 9.
Outcomes
Primary Outcomes
PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY
Time Frame: EVERY 5MIN PAIN RESPONSES IN THE FORM OF CHANGES IN HEART RATE AND BLOOD PRESSURES DURING SURGERY
Secondary Outcomes
- EMERGENCE AGITATION AT THE END OF SURGERY AS PAED SCORE, PAIN SCORES TILL 2HRS AFTER SURGERY AND NEED FOR RESCUE PAIN MEDICATION(EXTUBATION RESPONSE AT THE END OF SURGEY ,PAIN RESPONSE TILL 2HRS AFTER SURGERY, NEED FOR RESCUE PAIN RELIEVING MEDICATIONS TILL 2HRS AFTER SURGERY)
