| CTRI Number |
CTRI/2025/07/090175 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study for comparing of pain relief after surgery in children using either dexmedetomidine with ropivacaine or tramadol with ropivacaine for lower body operation |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of caudal Dexmedetomidine versus caudal Tramadol with Ropivacaine in paediatric infraumblical surgeries: A Prospective randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAINA SINGH |
| Designation |
Professor |
| Affiliation |
Jawahar Lal Nehru Medical College Ajmer Rajasthan |
| Address |
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAINA SINGH |
| Designation |
Professor |
| Affiliation |
Jawahar Lal Nehru Medical College Ajmer Rajasthan |
| Address |
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAINA SINGH |
| Designation |
Professor |
| Affiliation |
Jawahar Lal Nehru Medical College Ajmer Rajasthan |
| Address |
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology new OT 1st floor JLN medical college and hospital Kalabagh Ajmer Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
J L N Medical college |
| Address |
Kalabagh Ajmer Rajasthan 305001 |
| 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 Shashi Bala |
J L N Medical college and Hospital |
Department of Anaesthesiology SS OT 1st floor J L N Medical college and hospital kalabagh Ajmer
Ajmer
RAJASTHAN |
7860305222
shashi6325@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Jawahar Lal Nehru Medical college and Hospital Ajmer Rajasthan |
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 |
Injection Ropivacaine 0.75 percentage
injection Dexmedetomidine 2mcg per kg
Injection Tramadol 2mg per kg |
with due approval from institutional ethical committee a prospective Randomised study has been planned on 34 paediatric age group 1 to 8 year who will be undergoing infraumblical surgeries under caudal and general Anaesthesia. Participant will allotted into group RD receiving injection Dexmedetomidine and group RT receiving injection Tramadol as an adjuvant with local anaesthetic in above mention dose as a single injection will be compared for duration of analgesia. monitor till patient complains pain of post operative period. A written inform consent will be taken from participant prior the procedure. |
| Intervention |
Injection Ropivacaine 0.75 percentage injection Dexmedetomidine 2mcg per kg Injection Tramadol 2mg per kg |
With due approval from institutional ethical committee a prospective Randomised study has been planned on 34 paediatric age group 1 to 8 year who will be undergoing infraumblical surgeries under caudal and general Anaesthesia. Participant will allotted into group RD receiving injection Dexmedetomidine and group RT receiving injection Tramadol as an adjuvant with injection Ropivacaine 0.75 percent caudal as in above mention dose as a single injection will be compared for duration of analgesia. monitor till patient complains pain of post operative period. A written inform consent will be taken from participant prior the procedure. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
undergoing elective infraumblical surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
patient having history or evidence of infection at the back, allergy to drugs ,bleeding /coagulation disorder
history of developmental delay
sepsis |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
assessment of visual analogue for pain in post operative period at immediately after shifting post operative unit after 1hr,2hr, 3hr, 4hr, 6hr, 8hr, 10hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the duration of motor block, post operative |
5-point sedation score emergence time. FLACC pain score with its 0-10 score range each patient pain intensity will assessed 1hr 2hr 3hr 4hr 5hr 6hr,every 3hr till 12hr |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="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
|
This will be a prospective randomised study conducted to evaluate injection dexmedetomidine 2mcg/kg and inj. tramadol 2mg/kg as an adjuvant with injection ropivacaine 0.75% caudally in paediatric patient who are between 1 to 8yr old ASA grade 1 or 2 with exemption of all exclusion criteria mention above and undergoing infraumblical surgeries under caudal analgesia with primary objective of comparing the duration of analgesia secondary objective being onset and duration of sensory block and cardiovascular effect, side effect. Participant will be allocated in two group each with 17 sample size. Group RD receiving injection dexmedetomidine and group RT receiving injection Tramadol as an adjuvant with local anaesthetic caudal block in above mention doses. Pre anaesthetic evaluation will be done previous day, necessary pre medication will be given , informed written consent will be taken prior to surgery. All emergency drugs and equipment will kept ready in prior. Under all aseptic precaution respective drug will be given caudally to respective group of patient. Patient will be monitored intra operative and post operatively . All the parameter will be recorded at pre described interval and documented, data will be analyses statically using standard qualitative and quantitative test. Continuous variable will be analyse using student pair test and categorical variable will be analysed using chi-square test. P value is less than 0.5 will be consider significant. |