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A study comparing Buzzy device and Lignocaine injection to reduce pain of propofol injection in children

Prevention of pain on propofol injection in children using the Buzzy device versus pre injection with preservative free 2 percent Lignocaine, a randomized controlled study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080311
Enrollment
240
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: K439- Ventral hernia without obstructionor gangrene Health Condition 2: M679- Unspecified disorder of synovium and tendon Health Condition 3: Q35-Q37- Cleft lip and cleft palate Health Condition 4: K02- Dental caries Health Condition 5: K35-K38- Diseases of appendix Health Condition 6: L80-L99- Other disorders of the skin and subcutaneous tissue Health Condition 7: M20-M25- Other joint disorders Health Condition 8: N30-N39- Other diseases of the urinary system Health Conditio

Interventions

Intervention1: Buzzy device: In this arm of the study of randomised group of patients, children receive Buzzy device which combines a gel ice pack to provide cold sensation and a bee like vibrating de

Sponsors

Dr Kavya KG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 8 months to 10 years, males and females, belonging to ASA (American Society of Anesthesiologists) Physical status 1 and 2, undergoing surgery under General Anesthesia

Exclusion criteria

Exclusion criteria: The following are the exclusion criteria - Crying children despite use of intravenous anxiolytic injection, shock, hypotension, bradycardia, allergy to egg lecithin, children on preoperative analgesics and children who need sevoflurane based inhalational induction for intravenous cannulation

Design outcomes

Primary

MeasureTime frame
Assess the pain response to injection of propofol while using Buzzy device and compare it to the pain response seen with propofol injection when pre injection of preservative free 2% Lignocaine is givenTimepoint: Compare the Pain Scores between the two groups—

Secondary

MeasureTime frame
Assess change in heart rate to propofol injection while using Buzzy device & compare it with the change in heart rate to propofol injection when preinjection of preservative free 2 percent Lignocaine administered.Timepoint: Compare the heart rate responses between the two groups—

Countries

India

Contacts

Public ContactDr Kavya KG

Rangadore Memorial Hospital

drkavyakg@gmail.com9449004535

Outcome results

None listed

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