| CTRI Number |
CTRI/2025/10/095952 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cold and vibration analgesia on propofol injection pain in pediatric patients undergoing surgery |
|
Scientific Title of Study
|
Efficacy of cryo-vibro-analgesia on propofol injection pain in paediatric patients undergoing surgery under general anaesthesia: A randomised control 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 Khyati Jain |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, AIIMS BHOPAL, SAKET NAGAR, BHOPAL, MP
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7424947936 |
| Fax |
|
| Email |
jain.khyati2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor, Department Of Anaesthesiology |
| Affiliation |
AIIMS BHOPAL |
| Address |
Department of Anesthesiology and critical care, AIIMS BHOPAL, SAKET NAGAR, BHOPAL, MP
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor, Department Of Anaesthesiology |
| Affiliation |
AIIMS BHOPAL |
| Address |
Department of Anesthesiology and critical care, AIIMS BHOPAL, SAKET NAGAR, BHOPAL, MP
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY, AIIMS BHOPAL, SAKET NAGAR, BHOPAL, MP, India, Pin 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Zainab Ahmad |
| Address |
Department of Anesthesiology, AIIMS BHOPAL, Saket Nagar, Bhopal, MP, India - 462020 |
| 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 Khyati Jain |
AIIMS BHOPAL |
Department of Anesthesiology and critical care, AIIMS BHOPAL
Bhopal
MADHYA PRADESH |
7424947936
jain.khyati2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHOPAL Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryo-vibro-analgesia |
Cryo-vibro-analgesia using Buzzy device |
| Comparator Agent |
IV analgesia |
IV analgesia (Propofol-Lignocaine admixture) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II
Consenting parents or guardians
5-12 years old patients posted for elective non cardiac surgery.
Should be alert enough to respond and provide feedback for the procedure.
Should have availability of upper limb (venous access) for the procedure.
Planned for IV induction of anaesthesia.
Pre-existing free flowing cannula |
|
| ExclusionCriteria |
| Details |
On Sedation
IV line on lower limb
On mechanical ventilation
Peripheral Vascular Disease, pre-existing chronic pain/neuropathy
Significant edema or Thrombophlebitis in the limb
Modified Yale Preoperative Anxiety Scale (mYPAS) score more than 30 |
|
|
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 |
| Pain score on composite behavioral scale. |
During or immediately after propofol injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of pain experienced during or immediately after propofol injection in pediatric patients (5–12 years) using a combined cold and vibration device (cryo-vibro-analgesia with Buzzy® device) as compared to the lignocaine-propofol admixture. |
During or immediately after propofol injection. |
| To evaluate the tolerability of the Buzzy device in pediatric patients. |
During propofol injection. |
| To evaluate provider-reported ease of use. |
After propofol injection |
| To evaluate acceptability of device in pediatric patients |
On POD 1 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/10/2025 |
| 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="6"
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
|
Propofol is the most common intravenous anesthetic drug used for induction and maintenance of general anesthesia owing to its rapid onset, short duration and favourable safety profile. However, the incidence of pain following propofol injection is seen in approximately 70% patients. The methods of pain relief during propofol injection include pharmacological and non-pharmacological means. The most accepted technique is administration of lignocaine either mixed in the syringe or administered prior to injection of propofol. This study aims to evaluate effect of cryo-vibro-analgesia technique using Buzzy device on pain associated with propofol injection in children (5-12years) undergoing surgery under general anaesthesia. Though multiple studies have evidenced the role of Buzzy device and its cryo-vibro-analgesia on mitigation of pain in vaccinations and insertion of IV cannula, there is no study on its effectiveness in reducing propofol injection pain in children. In this study after taking written informed consent, patients will be randomized into either treatment or control group. In treatment group Buzzy device will be fixed 5cm above the cannulation site along with frozen wings and turned on for 1min before propofol injection. In control group Buzzy device will be applied similarly with unfrozen wings and not switched on. During the propofol injection, pain will be assessed and graded using a composite behavioral scale. Following induction the study will be terminated and monitoring will continue for 24 hours. |