| CTRI Number |
CTRI/2019/01/017329 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing the effect of pain relief provided by one combination of drug(Ketofol) with that of the other(Etofen)
|
|
Scientific Title of Study
|
A Randomised Controlled Trial Comparing the procedural sedative and analgesic actions of ketofol and etofen during procedures in the emergency department |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renukadabbara |
| Designation |
DNB Emergency Medicine resident |
| Affiliation |
Bangalore baptist hospital |
| Address |
Department of Emergency Medicine,Bangalore baptist hospital , Bellary road, Hebbal, Bangalore.560024.
Bangalore
KARNATAKA
560024
India |
| Phone |
8008857980 |
| Fax |
|
| Email |
renudabbara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreekanth wodeyar |
| Designation |
Consultant, Department of emergency medicine |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Department of emergency medicine ,Bangalore Baptist hospital, Bellary road,Hebbal,Bangalore,560024
Bangalore Baptist hospital,Bellary road,Hebbal,Bangalore,560024 Bangalore KARNATAKA 560024 India
Bangalore
KARNATAKA
560024
India |
| Phone |
7349617950 |
| Fax |
|
| Email |
wodeyar.sree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreekanth wodeyar |
| Designation |
Emergency medicine consultant |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Bangalore Baptist hospital,Bellary road,Hebbal,Bangalore, KARNATAKA 560024 India
Bangalore Baptist hospital,Bellary road,Hebbal,Bangalore, KARNATAKA 560024 India
Bangalore
KARNATAKA
560024
India |
| Phone |
7349617950 |
| Fax |
|
| Email |
wodeyar.sree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine,Bangalore Baptist Hospital, Bellary road, Hebbal, Bangalore - 560024 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine Bangalore Baptist Hospital Bellary road Hebbal Bangalore |
| Address |
Bangalore Baptist Hospital, Bellary road, Hebbal, Bangalore 560024 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dabbara Renuka |
Bangalore Baptist Hospital |
Department of Emergency mesicine, Bangalore Baptist Hospital,Bellary road,Hebbal,Bangalore,560024 Bangalore Karnataka
Bangalore
KARNATAKA |
8008857980
renudabbara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE BAPTIST INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T14-T14||Injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1)Hypersensitivity to Ketofol or Etofen 2)Age less than 18 years 3)ASA 3 and 4
|
Combination of etomidate and fentanyl. Intravenous administration Titrating dosage of etomidate(18 mg + fentayl 100mcg ) given according to the sedation and pain score
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who decided to receive PSA for procedures and ASA physical status 1 or 2 |
|
| ExclusionCriteria |
| Details |
1)Hypersensitivity to Ketofol or Etofen 2)Age less than 18 years 3)ASA 3 and 4
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain severity (visual analogue scale) 2) Adequacy of sedation and analgesia between two groups (Modified Ramsay Sedation Score) 3) Incidence of airway adverse events
|
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the other adverse effects between two groups (additional drug needed, sedation duration, sedation level and patient pain and physicians satisfaction scores) 2) To determine the alterations in hemodynamic changes between two groups
|
5min |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2019 |
| Date of Study Completion (India) |
08/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Procedural sedation and analgesia is the technique of administering sedatives or dissociative agents with or without analgesics to induce an altered state of consciousness that allows the patient painful and unpleasant procedures while preserving cardiorespiratory function.Recommended drugs for PSA propofol, ketamine, ketofol, alfentanyl,etofen.Procedures done commonly in emergency room include fracture reductions, intercostal tube drainage insertions, incision and drainage of abscess and other painful procedures requiring sedation and analgesia. |