| CTRI Number |
CTRI/2018/05/013920 [Registered on: 16/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the prolongation of pain relief in children after single dose of intravenous dexmetomidine with the block given in the lowest portion of spine |
|
Scientific Title of Study
|
Effect of single shot intravenous dexmedetomidine for the supplementation of caudal analgesia in children - a prospective randomized comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Aysha Edathodu |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New delhi. |
| Address |
Room number 5011,
Anaesthesiology office,
fifth floor Teaching block,
AIIMS,Ansari nagar , New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9540303301 |
| Fax |
|
| Email |
tanyaedathodu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganga Prasad |
| Designation |
Professor |
| Affiliation |
AIIMS, New delhi. |
| Address |
Room number 5011,
Anaesthesiology office,
fifth floor Teaching block,
AIIMS,Ansari nagar , New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9013232965 |
| Fax |
|
| Email |
drgpd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Aysha Edathodu |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New delhi. |
| Address |
Room number 5011,
Anaesthesiology office,
fifth floor Teaching block,
AIIMS,Ansari nagar , New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9540303301 |
| Fax |
|
| Email |
tanyaedathodu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS, Ansari nagar,New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Tanya Aysha Edathodu |
AIIMS , New Delhi |
AB8, Department of anesthesiology, New Delhi 110029
New Delhi
DELHI |
9540303301
tanyaedathodu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing urethroplasty., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group RD |
Intravenous dexmedetomidine 1 mcg/kg in 10ml NS over 10 minutes and caudal block with 0.75ml/kg of 0.25% ropivacaine. |
| Comparator Agent |
Group RS
|
Intravenous 10 ml of NS over 10 minutes and caudal block with 0.75ml/kg of 0.25% ropivacaine.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II
Age 2- 8 yrs
Undergoing urethroplasty |
|
| ExclusionCriteria |
| Details |
Parental or guardian refusal
Hypersensitivity to any local anaesthetic
Bleeding diathesis
Infection at puncture site
Children with uncorrected heart disease
Children with heart block or liver impairment
Preexisting neurological diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of intravenous dexmedetomidine on caudal analgesia , to compare the time to rescue analgesia. |
The duration of analgesia is from the time of caudal injection to the time of FLACC score 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of emergence agitation
To compare the time for discharge based on modified aldrete score.
To compare the postoperative sedation.
|
Sedation score will be assessed using Modified Ramsay’s sedation score
Time taken to achieve Aldrete score of 9 will be noted. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2016 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesthesia & Analgesia. 2000 Mar 1;90(3):699-705.
Coskuner I, Tekin M, Kati I, Yagmur C, Elcicek K. Effects of dexmedetomidine on the duration of anaesthesia and wakefulness in bupivacaine epidural block. European journal of anaesthesiology. 2007 Jun 1;24(06):535-40.
Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. European Journal of Anaesthesiology (EJA). 2010 Mar 1;27(3):247-52 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Dexmedetomidine is a short acting selective alpha 2 agonist with sedative anxiolytic and analgesic properties. It has been used as adjunct to general and regional anaesthesia in adults .In adults, there are studies showing analgesic action of Intravenous dexmedetomidine on epidural block.
After a vast literature search ,we found that there are limited studies on the effect of intravenous dexmedetomidine on caudal analgesia in children. We hypothesis that intravenous dexmedetomidine might prolong the caudal analgesia in children. Hence we planned to conduct this study to evaluate the efficacy of intravenous dexmedetomidine for the supplementation of caudal analgesia in children. the study results is statistically significant increase duration of analgesia with dexmedetomidine group of mean duration 425 minutes and that of saline group of 300 minutes
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