| CTRI Number |
CTRI/2024/02/062175 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs combination for post operative pain relief in adenotonsillectomy in children |
|
Scientific Title of Study
|
Peritonsillar infiltration with bupivacaine and dexamethasone versus ropivacaine and dexamethasone for post operative pain relief in adenotonsillectomy: A comparative study in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Jindal |
| Designation |
PG 2nd year Anesthesia Resident |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia S P Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
8685019180 |
| Fax |
|
| Email |
dr.divyajindal322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Pareek |
| Designation |
Senior Professor And Head |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia S P Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Pareek |
| Designation |
Senior Professor And Head |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia S P Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rajasthan |
| Address |
Department of Anaesthesiology
Sardar Patel Medical College
Bikaner Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Anita Pareek |
Sardar Patel Medical College Bikaner Rajasthan |
Department of Anaesthesiology Sardar Patel Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN |
982810281
dranitapareek23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Research Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J351||Hypertrophy of tonsils, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparision of peritonsillar infiltration with local anaesthetic drugs for post operative pain relief |
Comparision of peritonsillar infiltration with Bupivacaine and Dexamethasone versus Ropivacaine and Dexamethasone for post operative pain relief in Adenotonsillectomy in children |
| Intervention |
LOCAL INFILTRATION |
LOCAL INFILTRATION OF DRUGS IN ANTERIOR PILLAR OF TONSIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2, Planned for adenotonsillectomy, Age 2 to 12 years |
|
| ExclusionCriteria |
| Details |
Patient refusal, ASA PS>2, Allergy, Signs of acute pharyngeal infection, Peritonsillar abscess, Bleeding disorder, Use of regular analgesic medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of peritonsillar infiltration with bupivacaine and dexamethasone versus ropivacaine and dexamethasone for post operative pain relief in adenotonsillectomy in children inrelation to:
1. Duration of post operative analgesia.
2. Total dose of rescue analgesia in the first 24 hours postoperatively.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the haemodynamic parameters, To observe any post operative complication
|
24hrs |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Tonsillectomy,
with or without adenoidectomy, is one of the most frequent procedures performed
by otolaryngologists. However, controlling pain after this common procedure
still remains problematic. Poor pain control has a detrimental effect on patient’s well-being
and may result in increased risk of complications.This study will be aimed to identify the effectiveness of
different drugs (bupivacaine and dexamethasone vs ropivacaine and
dexamethasone) in managing post operative analgesia in paediatric patients
undergoing elective adenotonsillectomy.
|