| CTRI Number |
CTRI/2020/03/023680 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
26/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING THE EFFECTS OF TWO PAIN RELIEVING MEDICINES ON CHILDREN UNDERGOING THROAT SURGERIES |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JYOTHI RANI SAVLA |
| Designation |
PEDIATRIC ANAESTHESIA FELLOW |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA
4TH FLOOR OT COMPLEX
RAINBOW CHILDRENS HOSPITAL
ROAD NO 2 BANJARA HILLS
HYDERABAD
TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
9494266660 |
| Fax |
|
| Email |
rani.jyothi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SARITHA KUMARI |
| Designation |
CONSULTANT |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA
4TH FLOOR OT COMPLEX
RAINBOW CHILDRENS HOSPITAL
ROAD NO 2 BANJARA HILLS
HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9912665537 |
| Fax |
|
| Email |
dr_saritha_a28@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SARITHA KUMARI |
| Designation |
CONSULTANT |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA
4TH FLOOR OT COMPLEX
RAINBOW CHILDRENS HOSPITAL
ROAD NO 2 BANJARA HILLS
HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9912665537 |
| Fax |
|
| Email |
dr_saritha_a28@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| RAINBOW CHILDRENS HOSPITAL
ROAD NO 1 BANJARA HILLS
HYDERABAD TELANGANA 500034 |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [ACADEMIC STUDY] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JYOTHI RANI SAVLA |
RAINBOW CHILDREN HOSPITAL |
AXON ANAESTHESIA
4TH FLOOR OT COMPLEX
RAINBOW CHILDREN HOSPITAL
ROAD NO 2 BANJARA HILLS
Hyderabad
TELANGANA |
9494266660
rani.jyothi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE RAINBOW CHILDRENS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FENTANYL VS DEXMEDETOMIDINE |
INFUSION OF 2 MICROGRAM/KG OF FENTANYL IN 1 GROUP AND 1 MICROGRAM/KG OF DEXMEDETOMIDINE IN OTHER GROUP OF PATIENTS OVER 10 MIN IN THE PREOPERATIVE HOLDING AREA |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. AMERICAN SOCIETY OF ANAESTHESIOLOGISTS grades I & II.
2. Aged between 2-10 years of either sex.
|
|
| ExclusionCriteria |
| Details |
1. 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. ADHD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |