Effect of cold and vibration analgesia on propofol injection pain in pediatric patients undergoing surgery

Efficacy of cryo-vibro-analgesia on propofol injection pain in paediatric patients undergoing surgery under general anaesthesia: A randomised control study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095952

Enrollment

Registered

2025-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Cryo-vibro-analgesia: Cryo-vibro-analgesia using Buzzy device Control Intervention1: IV analgesia: IV analgesia (Propofol-Lignocaine admixture)

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Pain score on composite behavioral scale.Timepoint: During or immediately after propofol injection	—

Secondary

Measure	Time frame
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.Timepoint: During or immediately after propofol injection.;To evaluate the tolerability of the Buzzy device in pediatric patients.Timepoint: During propofol injection.;To evaluate provider-reported ease of use.Timepoint: After propofol injection;To evaluate acceptability of device in pediatric patientsTimepoint: On POD 1	—

Measure

Time frame

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.Timepoint: During or immediately after propofol injection.;To evaluate the tolerability of the Buzzy device in pediatric patients.Timepoint: During propofol injection.;To evaluate provider-reported ease of use.Timepoint: After propofol injection;To evaluate acceptability of device in pediatric patientsTimepoint: On POD 1

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Countries

India

Contacts

Public ContactDr Zainab Ahmad

AIIMS BHOPAL

drzainabhaq@gmail.com8860048951

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026