| CTRI Number |
CTRI/2025/05/086328 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pain Relief After Tonsil and Adenoid Surgery in Children: Diclofenac vs. Acetaminophen Suppositories |
|
Scientific Title of Study
|
Comparative study of post-operative analgesia using
Diclofenac sodium suppository vs Acetaminofen suppository in children undergoing
Adenotonsillectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandava Bharath kumar |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7382129266 |
| Fax |
|
| Email |
teja78488@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor,Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor,Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Mandava Bharath Kumar |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Mandava Bharath Kumar |
Dr. D.Y. Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7382129266
teja78488@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
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 |
Acetaminophen suppository |
Dose 20mg/kg
Inserted rectally post intubation
VAS score post-operatively at 10,20 min then hourly till the patient is given rescue analgesia |
| Intervention |
Diclofenac sodium suppository |
Dose 2mg/kg
Inserted rectally post intubation
VAS score post-operatively at 10,20 min then hourly till the patient is given rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Patients aged between 5 and 12 years of age.
3. Patients undergoing elective adenotonsillectomy pediatric surgery.
4. Written informed consent from the concerned patient guardian |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study.
2. Patients with ASA grade III and above physical status.
3. Patients who are posted for emergency procedures.
4. Patients with known allergy to the study drugs.
5. Patients who have psychiatric, coagulopathies, neurological, neuromuscular, or
cardiovascular disease or impairment of hepatic or renal function.
6. Patients with inflammatory conditions of rectum and anal canal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Visual Analogue Scale(VAS) score post operatively |
At 10 and 20
mins, and then hourly, till patients received rescue analgesic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Visual Analogue Scale(VAS) score post operatively in children undergoing adenotonsillectomy |
Duration of analgesia will be assessed post
surgery once the effects of the suppository decrease &
time to rescue to analgesia will be assessed 2
hours after surgery & hourly until intervention is required |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
23/05/2025 |
| 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="1"
Months="6"
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
|
It is a prospective, randomized, double blinded comparative study to compare the the post-operative analgesia using diclofenac sodium and acetaminophen suppositories in children undergoing adenotonsillectomy
Parameters that will be compared between the two groups will be the the onset and duration of analgesia and time to rescue analgesia
|