| CTRI Number |
CTRI/2025/03/082644 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Pain relief with application of Cooling Device (gel ice pack) versus Vibration (Buzzy Device®) for Arterial Puncture related Pain : A Randomised Study |
|
Scientific Title of Study
|
Cryo-Analgesia versus Vibro-analgesia for Reducing Arterial Puncture Associated
Pain: A Randomised Cross-over Study |
| 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 Chitra |
| Designation |
Junior Resident (Academic), Department Of Anaesthesiology |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8332910052 |
| Fax |
|
| Email |
chitrasrinivas38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra |
| Designation |
Junior Resident (Academic), Department Of Anaesthesiology |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
MADHYA PRADESH
462020
India |
| Phone |
8332910052 |
| Fax |
|
| Email |
chitrasrinivas38@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor, Department Of Anaesthesiology |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS,Saket Nagar, Bhopal, Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Bhoapl |
|
|
Primary Sponsor
|
| Name |
Dr Zainab Ahmad |
| Address |
Department of Anaesthesiology, 3rd Floor, Above Trauma Complex, AIIMS, Saket Nagar, Bhopal, Madhya Pradesh, India 462020 |
| Type of Sponsor |
Other [] |
|
|
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 Chitra |
All India Institute Of Medical Sciences, Saket Nagar, Bhopal, MP, India - 462020 |
SICU, 2nd Floor, Near Modular OT Complex -2, Department of Anaesthesiology, AIIMS, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH |
8332910052
chitrasrinivas38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research, AIIMS, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buzzy Device ® |
Buzzy Device ® provides both cryo-analgesia and vibro-analgesia. 11 Point NRS Pain score will be recorded after application of cryo analgesia before arterial puncture. |
| Comparator Agent |
Buzzy Device ® |
Buzzy Device ® provides both cryo-analgesia and vibro-analgesia. 11 Point NRS Pain score will be recorded after application of vibro analgesia before arterial puncture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
a. 18-65 years old patients admitted to the SICU/MICU for any indication
b. Patient should be requiring repeated (at least 2) arterial blood gas analysis for any
indication (example repeated potassium measurement for ongoing correction)
c. Should be alert enough to respond and provide feedback for the procedure
d. Should have availability of upper limb (radial artery) for the procedure with viable
collateral circulation
e. Able to understand either Hindi or English |
|
| ExclusionCriteria |
| Details |
a. n Sedation
b. On Mechanical Ventilation
c. Peripheral Vascular Disease, pre- existing chronic pain / neuropathy
d. Radial puncture not possible
e. Significant edema in the limb
f. Not giving consent
g. Hypovolemic
h. Patient on high dose vasopressors, inotropic agents
i. Already in significant pain at the time of ABG
j. Opioid Dependent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain measured using the NRS 11 Point Score at the time of arterial
puncture |
Immediately 5 minutes after application of intervention(vibration/gel ice pack application.
Minimum duration between both interventions is 4 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a) Number of attempts to gain an arterial blood sample
(b)Memory of pain (1st & 2nd Prick) after 12 hours on VAS score |
12 hours of the last intervention |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
25/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The methods of pain relief during arterial puncture include pharmacological (infiltration or topical application of local anaesthetics) and non-pharmacological techniques (cryo-analgesia or local anaesthetic infiltration may cause its own pain along with obscuring landmarks. Topical anaesthetic application is associated with vasoconstriction and lower success rate. The nonpharmacological techniques have not yet gained popularity because of unavailability and inadequate knowledge regarding their efficacy. The efficacy of cryo-analgesia and vibro-analgesia is attributed to the concept of gate control theory of pain. The principle behind buzzy device ® is gate control theory of pain; alternatively cold stimulus triggers the descending noxious inhibitory controls , activating supraspinal modulation and increasing the overall pain threshold of the body. Many studies have been conducted with Buzzy devices for venipuncture pain, which have shown good results. |