A Comparative Analysis of Pain Reduction in IV Cannulation Between Immediate and Delayed Application of Lignocaine as Local Anaesthetics
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Comparison of pain reduction after immediate and delayed application of local anesthetic during IV cannulation
Study Overview
Brief Summary
Pediatric patients often experience anxiety and pain during medical procedures, such as intravenous cannula insertion, which can lead to distress, decreased compliance, and potential procedural delays. Despite the prevalence of such procedures, there is limited evidence on the most effective pain management strategies, particularly the use of local anesthetics. This study aims to address this gap through a randomized trial evaluating the efficacy of local anesthetics in reducing post-insertion pain. Effective pain management can improve patient comfort, mitigate long-term psychological impacts like needle phobia, enhance procedural compliance, and optimize healthcare resource utilization. By advancing evidence-based practices, this research supports the ethical imperative of ensuring pediatric well-being and promoting patient-centered care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 8.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age Range: Children aged 8 to 18 years old.
- •Consent: Written informed consent from parents or guardians and assent from children aged 7 and above.
- •Procedure: Children scheduled for elective intravenous cannula insertion as part of medical treatment or diagnostic procedures.
- •Health Status: ASA (American Society of Anesthesiologists) physical status classification I or II.
- •Previous Experience: Children with no previous negative experience with IV cannulation to avoid psychological biases.
- •Communication: Ability to understand and communicate pain levels using age-appropriate pain scales.
- •Stable Condition: Children who are in a stable medical condition and not in acute distress.
Exclusion Criteria
- •Allergies: Known allergy or sensitivity to local anesthetics (e.g., lidocaine, prilocaine).
- •Skin Conditions: Presence of skin infections, dermatitis, or other skin conditions at the site of cannula insertion.
- •Medical Conditions: Children with chronic pain conditions or on regular pain medication.
- •Cooperation: Children who are unable to cooperate or follow instructions due to developmental delays, severe anxiety, or other behavioral disorders.
- •Recent Procedures: Children who have undergone IV cannulation within the past month to avoid sensitization or tolerance.
- •Weight: Extreme underweight or overweight children where standard dosing of local anesthetic may not apply appropriately.
- •Parental Refusal: Parents or guardians who refuse the use of local anesthetic for the procedure.
- •Language Barrier: Families unable to communicate effectively in the language used for the study without the aid of an interpreter.
Outcomes
Primary Outcomes
Comparison of pain reduction after immediate and delayed application of local anesthetic during IV cannulation
Time Frame: 1 year
Secondary Outcomes
- Onset and duration of pain relief after application of local anesthetic(1 year)
Investigators
PURVI PATEL
Pramukhswami medical college, Karamsad