| CTRI Number |
CTRI/2026/01/100289 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Testing Tramadol with Ropivacaine for Better Pain Control in Children After Surgery |
|
Scientific Title of Study
|
A Randomized Controlled study to evaluate Effectivness of Tramadol as an Adjuvant to caudal Ropivacaine for postoperative Analgesia in lower Abdominal surgeries in Pediatric Patients Under Anesthesia at SMS Medical college Jaipur |
| 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 RAMA CHATTERJEE |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLAGE JAIPUR |
| Address |
Department of Anaesthesiology
SMS MEDICAL COLLEGE AND HOSPITAL
JAIPUR
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
919828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAMA CHATTERJEE |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLAGE JAIPUR |
| Address |
Department of Anaesthesiology
SMS MEDICAL COLLEGE AND HOSPITAL
JAIPUR
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
919828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JASPAL BAROD |
| Designation |
Junior resident |
| Affiliation |
SMS medical collage jaipur |
| Address |
Department of Anaesthesiology SMS Medical college and Hospital Jaipur Rajasthan 302004 India
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8890497374 |
| Fax |
|
| Email |
jaspalbarod98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deparment Of Anaesthesiology SMS Medical College and Hospital Jaipur Rajasthan 302004 india |
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLAGE JAIPUR |
| Address |
Department of Anaesthesiology SMS Medical college and Hospital Jaipur Rajasthan 302004 India |
| 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 rama chatterjee |
SMS Medical college and Hospital |
Department of Anaesthesiology SMA Medical college and Hospital Jaipur
Rajasthan 302004
Jaipur
RAJASTHAN |
9828622026
chatterjeerama30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics committee SMS Medical College Jaipur |
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 |
| Intervention |
Caudal block in pediatric patient in lower abdominal surgery in general anesthesia |
To access the effect of caudal
block with .2% isobaric ropivacaine inj.with 2mg/kg tramadol on post op analgesia in pediatric patients in lower abdominal surgery under general anesthesia.
frequency single time
route of administration- intrathecal
duration of intervention -single injection.
|
| Comparator Agent |
Injection Ropivacaine 0.2% at a dose of 1 ml/kg |
Patients allocated to the comparator group will receive:
• Injection Ropivacaine 0.2% at a dose of 1 ml/kg
The drug will be administered as a single bolus caudal injection without the addition of any adjuvant.
The comparator is used to evaluate the effectiveness of adding tramadol as an adjuvant to ropivacaine by comparing duration of postoperative analgesia, pain scores, sedation scores, hemodynamic parameters, and requirement of rescue analgesia. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1)Parents/ Guardian willing to give consent for the study
2)Children undergoing elective lower abdominal surgery
3)Patients of either sex
4)Age ranging between 1-5 years of age
5)ASA Grade I and II
6)Weight less than 20 kilogram
5) |
|
| ExclusionCriteria |
| Details |
1)History of allergic reactions to drugs used in study
2)Local infection at the proposed site of puncture for caudal block
3)History of developmental dealy
4)History of neurological deficit or verbal deformity
5)Patients on anticoagulant therapy and History of coagulation disorders
6)Patient shuld not be a part of any other study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first requirment to rescue analgesia measured from completion of surgery upto 24 hours postoperatively |
end of surgery,30-minute ,1 hour ,1 hour 30-minute,2-hour,4-hour,6-hour,12-hour,24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
hemodynamic parameters(HR,SBP,DBP,SPO2) upto 24 hour
|
end of surgery,30-minute ,1 hour ,1 hour 30-minute,2-hour,4-hour,6-hour,12-hour,24 hour |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="2"
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
|
This study is a hospital-based, randomized interventional trial conducted at SMS Medical College, Jaipur, to evaluate the effectiveness of tramadol as an adjuvant to caudal ropivacaine for postoperative analgesia in pediatric patients undergoing lower abdominal surgeries under general anesthesia. A total of 60 children aged 1–5 years, belonging to ASA physical status I–II, will be randomly allocated into two groups. Group I will receive caudal ropivacaine 0.2% (1 ml/kg), while Group II will receive caudal ropivacaine 0.2% (1 ml/kg) with tramadol 2 mg/kg. The primary outcome will be time to first rescue analgesia within 24 hours postoperatively. Secondary outcomes include postoperative pain assessment using FLACC scale, sedation assessment using Wisconsin sedation score, hemodynamic parameters, number of rescue analgesic doses, and incidence of adverse effects. The study aims to determine whether addition of tramadol prolongs duration and improves quality of postoperative analgesia without increasing adverse effects. |