| CTRI Number |
CTRI/2025/04/084633 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study pain relief in children after tonsillectomy by giving Levobupivacaine with Dexmedetomidine or Dexamethasone locally around tonsils.
|
|
Scientific Title of Study
|
Comparative study between Levobupivacaine Plus Dexmedetomidine versus Levobupivacaine plus Dexamethasone Infiltration for Post-Tonsillectomy Analgesia
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumedha Mehta |
| Designation |
Professor |
| Affiliation |
Smt kashibai Navale medical College and General Hospital |
| Address |
Department of Anesthesia, SKNMC and GH Narhe Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9923091187 |
| Fax |
|
| Email |
drsumedhamehta1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumedha Mehta |
| Designation |
Professor |
| Affiliation |
Smt kashibai Navale medical College and General Hospital |
| Address |
Department of Anesthesaia 3 rd Floor, SKNMC and GH, Narhe, Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9923091187 |
| Fax |
|
| Email |
drsumedhamehta1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedha Mehta |
| Designation |
Professor |
| Affiliation |
Smt kashibai Navale medical College and General Hospital |
| Address |
Department of Anesthesia 3 rd floor, SKNMC and GH, Narhe, Pune 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9923091187 |
| Fax |
|
| Email |
drsumedhamehta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Smt. Kashibai Navale Medical College General Hospital Narhe Pune Maharashtra India 411041 |
|
|
Primary Sponsor
|
| Name |
Dr Sumedha Mehta |
| Address |
Department of Anaesthesiology Smt. Kashibai Navale Medical College General Hospital |
| Type of Sponsor |
Other [Dr Sumedha Mehta] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ankita Patil |
Department of Anaesthesiology Smt. Kashibai Navale Medical College General Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumedha Mehta |
Smt kashibai Navale Medical College and General Hospital,Pune |
Department of Anesthesia,3rd Floor, SKNMC and GH Narhe Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9923091187
drsumedhamehta1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Kashibai Navale Medical college and General hospital Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Enlarged Tonsils |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine 0.25% 2.5ml plus Dexamethasone 0.25mg/kg will be given only once before tonsilar surgery for analgesia. |
Peritonsillar fossa will be infiltrated with Levobupivacaine 0.25% 2.5ml plus Dexamethasone 0.25mg/kg before starting surgery. |
| Intervention |
Levobupivacaine 0.25% 2.5ml plus dexmedetomidine 1mcg/kg only once before surgery for analgesia. |
Peritonsillar fossa will be infiltrated with Levobupivacaine 0.25% 2.5ml plus dexmedetomidine 1mcg/kg before starting the surgery. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Physical status ASA 1 and 2. |
|
| ExclusionCriteria |
| Details |
Refusal for participation
Inadequate NBM
Bleeding disorder, Active Upper respiratory infection, Emergency surgery. |
|
|
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 |
| Duration of postoperative analgesia from start of peritonsillar infiltration with study drug till first rescue analgesia given at when CHEOPS score is more than 5 or Wong Baker pain scale more than 4 postoperatively. |
Time from peritonsillar infiltration of study drugs till first rescue analgesia given postoperatively.Total number of Analgesia in 24hrs postopertively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total number of rescue analgesic dosages consumed in 24 hours postoperatively.
2) For the first 24 hours after surgery, the total oral intake (fluids and semisolids).
3) Perioperative side effects: such as hypotension, hypertension,
tachycardia, bradycardia, hypoxia, arrhythmia, excessive secretions, bleeding, respiratory depression, nausea,
and vomiting will be noted.4) Ramsay sedation scale.5) CHEOPS score and VAS score postoperatively. |
From the time of study drug administration till 24hrs postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We want to do the study to compare the intraoperative and postoperative analgesic effects of peritonsillar infiltration of Levobupivacaine 0.25% with either dexmedetomidine or dexamethasone in pediatric patients undergoing elective tonsillectomy. |