| CTRI Number |
CTRI/2010/091/001215 [Registered on: 14/09/2010] |
| Last Modified On: |
27/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision two different doses of caudal clonidine in combination with a single large per rectal dose of paracetamol for post operative pain relief in children. |
|
Scientific Title of Study
|
Comparision two different doses of caudal clonidine in combination with a single large per rectal dose of paracetamol for post operative pain relief in children - A prospective, randomized double-blind 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.Varadharajan.N |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesiology
5th floor, Teaching block,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
varadhanmdrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varadharajan.N |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesiology
5th floor, Teaching block,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
varadhanmdrd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varadharajan.N |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesiology
5th floor, Teaching block,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
varadhanmdrd@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,
Ansari nagar,
New delhi - 110029
India |
|
Primary Sponsor
Modification(s)
|
| Name |
AIIMS |
| Address |
Ansari nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof.M.K.Arora, Department Of Anaesthesiology, 5th Floor, Teaching Block, AIIMS, New Delhi-110029
Email ID-Mkarora442@Gmail.Com (All letters in email ID are in small letters) |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof.M.K.Arora |
AIIMS |
Ansari Nagar,Dept. of Anaesthesiology, AIIMS-110029
New Delhi
DELHI |
01126593516
mkarora442@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics sub-committee, AIIMS, New delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Post operative pain in children undergoing elective surgery in infraumbilical region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine in caudal block together with single large dose of rectal paracetamol |
Bupivacaine 0.25% 1ml/kg in caudal block,
Rectal paracetamol 30 to 40 mg/kg single dose |
| Intervention |
Clonidine with Bupivacaine in caudal block together with a single large dose of rectal paracetamol |
Clonidine 1mcg/kg Vs 2mcg/kg,along with
Bupivacaine 0.25% 1ml/kg,max dose 25 ml in caudal block,
Rectal paracetamol 30 to 40 mg/kg single dose |
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 2-8 years,
2)ASA status 1 or 2,
3)Elective surgery in lower abdomen, genitourinary and lower limb regions |
|
| ExclusionCriteria |
| Details |
1)Refusal by parents or guardians,
2)Children undergoing ano-rectal surgeries,
3)Presence of renal or liver dysfunction,
4)Presence of spinal deformities,
5)History of allergy to local anaesthetics,
6)History of bleeding disorder,
7)Presence of local infection at the site of block |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score post operatively - Visual Analogue Scale in >5yrs age group, Modified Objective Pain Score in <5yrs age group |
Upto 24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of Clonidine if occurs |
Upto 24 hours post operative period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/08/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A prospective randomized double-blind study comparing Clonidine in caudal block in two different doses (1mcg/kg Vs 2mcg/kg)together with Bupivacaine 0.25%,1ml/kg in combination with a single 30 to 40 mg/kg per rectal dose of paracetamol for post operative pain relief in children undergoing elective surgery in infraumbilical regions. |