| CTRI Number |
CTRI/2018/02/011779 [Registered on: 08/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Assess efficacy of Per Protocol Management of Pain relief in Trauma Patients at the emergency] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Is Pain relief for accident victims in the Emergency Department adequate? |
|
Scientific Title of Study
|
Assessment of Post Trauma Analgesia 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 |
Dr Vivekanand Chandrakumar |
| Designation |
Fellowship Registrar, Accident and Emergency Department |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Accident and Emergency Medicine,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
08098848218 |
| Fax |
|
| Email |
vivekanand.chandrakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paul Prabhakar Abhilash Kundavaram |
| Designation |
In Charge : Department of Emergency Medicine |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Accident and Emergency Medicine,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
09994924743 |
| Fax |
|
| Email |
kppabhilash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Chandrakumar |
| Designation |
Fellowship Registrar, Accident and Emergency Department |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Accident and Emergency Medicine,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
08098848218 |
| Fax |
|
| Email |
vivekanand.chandrakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College
Ida Scudder Road, Vellore, Tamil Nadu 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Department of Accident and Emergency Medicine,
Christian Medical College, Vellore |
| Type of Sponsor |
Private 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 Vivekanand Chandrakumar |
Christian Medical College |
Department of Accident and Emergency Medicine
Vellore
TAMIL NADU |
08098848218
vivekanand.chandrakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (BLue, Research and Ethics Committee), Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients greater than 18 years of age presenting with Post traumatic pain to the Emergency Department, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator – Analysis of Pre Protocol decrease in pain score in trauma patients presenting to the Emergency Department |
Patients with a pain score of 4 or less and Patients with a score of more than 4. Informed consent of the patient will be taken after which the Patient will be asked to grade his/her pain using the Comprehensive Pain Assessment Sheet at presentation to the Emergency Department. Analgesia administration will not be delayed in order to complete the study. The primary investigator will be blinded to the analgesia administered and will not be involved in the administration of pain relief. Time interval between patient presentation and primary analgesia will be documented and analgesic administered will also be documented. After an interval of half an hour and after 1 hour from administration of analgesic the patient will be asked to grade his/her pain again using the same Performa in order to assess relief of patient’s pain in the Emergency.
Patients in the Pre Protocol Phase will be used as the control in this Controlled Clinical Trial. |
| Intervention |
Intervention – Analysis of decrease in the pain score of trauma patients presenting to the ED treated with analgesia on the basis of the Pain Protocol |
The pain protocol involves an educational programme that will inform the ED registrars about the importance of early and appropriate management of pain and regarding the pain protocol.
The pain protocol for this study divides patients into two categories based on their pain score –
•Pain Score less than or equal to 4 – Inj Paracetamol 1g in 100ml NS iv over 10 min
•Pain Score more than 4 – Inj Morphine 0.1mg/kg iv and Inj Paracetamol 1g in 100ml NS iv over 10 min
These drugs shall be administered to all patients in the Post protocol phase if there is no contraindication to the mentioned drugs.
Patients are divided into those with a pain score of 4 or less and Patients with a score of more than 4. Informed consent of the patient will be taken after which the Patient will be asked to grade his/her pain using the Comprehensive Pain Assessment Sheet at presentation to the Emergency Department. Analgesia administration will not be delayed in order to complete the study. The primary investigator will be blinded to the analgesia administered and will not be involved in the administration of pain relief.
Time interval between patient presentation and primary analgesia will be documented and analgesic administered will also be documented.
After an interval of half an hour and after 1 hour from administration of analgesic the patient will be asked to grade his/her pain again using the same Performa in order to assess relief of patient’s pain in the Emergency.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 18 years of age presenting with Post Traumatic pain to the Trauma Bay of the Emergency Department |
|
| ExclusionCriteria |
| Details |
1) Unconscious, disoriented patients
2) Pregnant patients
3) Patients under the influence of drugs including alcohol
4) Patients presenting with chest pain irrespective of cause
5) Patients presenting with life or limb threatening conditions associated with pain
6) Patients with documented history of analgesia use for the same incident
7) Patients with history of Loss of consciousness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Decrease of Pain Score in Trauma Patients in the Emergency Department with implementation of the protocol - Yes/No and if significant |
On arrival, Half an hour and One hour from administration of primary analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to analgesic administration |
Half an hour and one hour after administration |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
Final Enrollment numbers achieved (Total)= "164"
Final Enrollment numbers achieved (India)="164" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2015 |
| Date of Study Completion (India) |
25/06/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Brief Summary - Pain is a very common
complaint in the Emergency Department and severe pain is often caused due to
trauma. Therefore an essential part of the management of such patients is
relief of pain. Unfortunately pain evaluation and assessment is often bypassed
in the Emergency due to lack of time and improper application of pain
assessment tools. The study will consist of two arms – the Pre Protocol arm and the Per Protocol
arm.
This
study aims to assess the baseline (Pre Protocol) adequacy of the analgesia by
follow-up assessment of the patient’s pain at half hourly intervals offering a
clearer picture of pain management in the ED. This study also aims to implement
a pain protocol and assess the impact of the protocol on the above mentioned
parameters to assess if standardization of medication improves pain relief in
the ED. The
pain protocol involves an educational programme that will inform the ED
registrars about the importance of early and appropriate management of pain and
regarding the pain protocol. The
pain protocol for this study divides patients into two categories based on
their pain score – ·
Pain Score ≤ 4 – Inj Paracetamol 1g in 100ml NS iv over 10
min
·
Pain Score > 4 – Inj Morphine 0.1mg/kg iv and Inj
Paracetamol 1g in 100ml NS iv over 10 min These
drugs shall be administered to all patients in the Post protocol phase if there
is no contraindication to the mentioned drugs. |