| CTRI Number |
CTRI/2025/11/097713 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing intravenous paracetamol and ibuprofen in pediatric cleft palate surgeries for post operative analgesia |
|
Scientific Title of Study
|
Comparing pain management outcomes: Pre-emptive intravenous Paracetamol versus Ibuprofen in pediatric cleft palate surgeries under General Anaesthesia - a single blinded randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanushree Potluri |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, KLE Academy of Higher Education, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8790721144 |
| Fax |
|
| Email |
tanushree.potluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Purvashree Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, KLE Academy of Higher Education, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7026083555 |
| Fax |
|
| Email |
purvashreedeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanushree Potluri |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, KLE Academy of Higher Education, Nehru Nagar, Belagavi, Karnataka
KARNATAKA
590010
India |
| Phone |
8790721144 |
| Fax |
|
| Email |
tanushree.potluri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, KLE University, Nehru Nagar, Belagavi, Karnataka, India, Pincode - 590010 |
|
|
Primary Sponsor
|
| Name |
Tanushree Potluri |
| Address |
Jawaharlal Nehru Medical College, KLE Academy of Higher Education, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
| 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 Tanushree Potluri |
Jawaharlal Nehru Medical College, KLE University |
Room no. 56, Department of Anaesthesiology, Jawaharlal Nehru Medical College, KLE Academy of Higher Education, Nehru Nagar, Belagavi, Karnataka - 590010
Belgaum
KARNATAKA |
8790721144
tanushree.potluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q359||Cleft palate, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ibuprofen |
Intravenous Ibuprofen is given pre-emptively as a single dose of 10mg/kg body weight in cleft palate surgeries to reduce post operative pain. |
| Comparator Agent |
Paracetamol |
Intravenous Paracetamol is given pre-emptively as a single dose of 15mg/kg body weight in cleft palate surgeries for post operative pain management |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 1-5yrs, ASA grade I and II, undergoing cleft palate surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
patients of ASA grades III or IV, hypersensitive to NSAIDs or those with existing cardiac or respiratory disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of paracetamol and ibuprofen for postoperative pain for cleft palate surgeries |
Pain score immediately assessed after completion of surgery when patient is shifted to the recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of ibuprofen & paracetamol in reducing post operative opioid consumption in cleft palate surgeries |
24 hours after surgery |
| stable post operative hemodynamics for cleft palate surgeries |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
30/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Postoperative pain management is a critical aspect of patient care in cleft lip and cleft palate surgeries. Cleft palate repair surgery can be associated with significant postoperative pain, discomfort, and distress for the child, highlighting the necessity for adequate pain management strategies. Non-opioid analgesics such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and gabapentinoids optimize pain relief while minimizing opioid use. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. Intravenous administration of ibuprofen allows for rapid onset of action, making it useful for managing acute pain in postoperative or perioperative settings. It can be particularly beneficial in multimodal pain management approaches. Healthcare providers use the CHIPPS score, or Children’s International Postoperative Pain Scale, to systematically evaluate and quantify postoperative pain in children, allowing for more effective pain management strategies to be implemented. The CHIPPS score evaluates pain intensity, behavior, and facial expression to provide a comprehensive assessment of pain in children. |