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Clinical Trials/CTRI/2020/03/023680
CTRI/2020/03/023680RecruitingNot Applicable

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

NOT APPLICABLE1 site in 1 country120 target enrollmentStarted: February 3, 2020Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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)

Investigators

Sponsor
NOT APPLICABLE
Sponsor Class
Other [ACADEMIC STUDY]

Study Sites (1)

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