Health Condition 1: R10-R19- Symptoms and signs involving the digestive system and abdomen
Conditions
Interventions
Intervention1: Midazolam group (Group A): IV midazolam 0.05–0.1 mg/kg (max 2 mg) administered, 10 minutes before induction (total duration of intervention is 10 minutes)
Control Intervention1: Melaton
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 5–15 years (either gender) ASA physical status 1-2 Scheduled for elective infra-umbilical laparoscopic abdominal surgery ( appendectomy, hernia repair, orchidopexy) Informed consent from parent/guardian and assent from child when appropriate
Exclusion criteria
Exclusion criteria: Known allergy to study drugs or local anesthetics Coagulopathy or local infection at block site Congenital spinal anomaly Significant cardiac conduction abnormality Developmental delay or cognitive impairment precluding questionnaire completion Obstructive sleep apnea requiring admission Active respiratory infection Anticipated need for postoperative ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare Paediatric Quality of Recovery (PedSQoR) scores between 24 hours preoperatively(baseline) and 24 hours post-surgery among children receiving melatonin, midazolam, or play therapy preoperatively in addition to a standardized caudal blockTimepoint: preoperatively- 24 hrs before surgery postoperatively- 24 hrs after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the incidence of perioperative anxiety mYAPS score in each group before induction PACU Face, Legs, Activity, Cry, & Consolability FLACC pain scores at arrival, 15, 30, 60 minutes Total perioperative opioid consumption (µg/kg) Time to first rescue analgesic Emergence delirium- Paediatric Anesthesia Emergence Delerium PAED score in PACU Incidence of PONV Length of hospital stay Parental satisfaction score at 24 hours (5-point Likert scale) Adverse events: paradoxical agitation, bradycardia/hypotension, desaturation, block-related complications, Local Anesthesia Systemic toxicity (LAST ) Timepoint: During surgery, 24 hrs post surgery & 48 hrs post surgery | — |
Countries
India
Contacts
Public ContactNishant Patel
AIIMS,New Delhi
Outcome results
None listed