COMPARING THE EFFECTS OF TWO PAIN RELIEVING MEDICINES ON CHILDREN UNDERGOING THROAT SURGERIES

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/03/023680
• Lead Sponsor: NOT APPLICABLE

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• AMERICAN SOCIETY OF ANAESTHESIOLOGISTS grades I & II.
• Aged between 2-10 years of either sex.

Exclusion Criteria

• Emergency procedures 2.
• Anticipated difficult airway 3.
• Presence of neck mass 4.
• Unstable cardiopulmonary condition 5.
• Pre-existing laryngeal or tracheal pathology 6.
• Contraindication to dexmedetomidine 7.
• History of any recent LRTI 8.
• Bleeding diathesis 9.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY	EVERY 5MIN PAIN RESPONSES IN THE FORM OF CHANGES IN HEART RATE AND BLOOD PRESSURES DURING SURGERY

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

RAINBOW CHILDREN HOSPITAL; 🇮🇳 Hyderabad, TELANGANA, India

RAINBOW CHILDREN HOSPITAL

🇮🇳Hyderabad, TELANGANA, India

DR JYOTHI RANI SAVLA

Principal investigator

9494266660

rani.jyothi5@gmail.com