| CTRI Number |
CTRI/2024/12/078718 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for reducing pain intensity in children with neuropathic pain |
|
Scientific Title of Study
|
Comparison of efficacy of Gabapentin and Pregabalin in reducing pain intensity in children with Guillain Barre syndrome 4-18 years of age: a single blind randomized controlled pilot 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 |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics, Pediatric Neurology Division
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics, Pediatric Neurology Division
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics, Pediatric Neurology Division
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Nagar, Rishikesh, Uttarakhand, Pin-249203 |
|
|
Primary Sponsor
|
| Name |
Prateek Kumar Panda |
| Address |
6th Floor, Department of Pediatrics, AIIMS, Rishikesh, Uttarakhand, Pin-249203 |
| 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 Prateek Kumar Panda |
All India Institute of Medical Sciences, Rishikesh |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gabapentin |
10 mg/kg/day daily orally tablets in three divided doses for seven days |
| Comparator Agent |
Pregabalin |
3.5 mg/kg/day daily orally tablets in three divided doses for seven days |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of GBS
Presence of neuropathic pain with severity measured by visual analogue score of 4 or more
|
|
| ExclusionCriteria |
| Details |
Any major chronic systemic illness
Previous documented allergy to either gabapentin or pregabalin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity in bilateral legs measured by the investigator using the visual analog scale on a scale of 0-10 |
Day 3 and day 7 after starting study medication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain intensity in back measured by the investigator using the visual analog scale on a scale of 0-10 |
Day 3 and day 7 after starting study medication |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="3"
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 single-blind randomized controlled trial will recruit children aged 4-18 with a confirmed diagnosis of Guillain Barre syndrome and neuropathic pain. Forty children will be randomized to receive either oral gabapentin or pregabalin for seven days. We will measure the pain intensity in bilateral legs and back on day 3 and day 7 after starting the study medication and compare the results between both groups. |