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To study pain relief in children after tonsillectomy by giving Levobupivacaine with Dexmedetomidine or Dexamethasone locally around tonsils.

Comparative study between Levobupivacaine Plus Dexmedetomidine versus Levobupivacaine plus Dexamethasone Infiltration for Post-Tonsillectomy Analgesia - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084633
Enrollment
60
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Levobupivacaine 0.25% 2.5ml plus dexmedetomidine 1mcg/kg only once before surgery for analgesia.: Peritonsillar fossa will be infiltrated with Levobupivacaine 0.25% 2.5ml plus dexmedeto

Sponsors

Dr Sumedha Mehta
Lead Sponsor
Dr Ankita Patil
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Physical status ASA 1 and 2.

Exclusion criteria

Exclusion criteria: Refusal for participation Inadequate NBM Bleeding disorder, Active Upper respiratory infection, Emergency surgery.

Design outcomes

Primary

MeasureTime frame
Duration of postoperative analgesia from start of peritonsillar infiltration with study drug till first rescue analgesia given at when CHEOPS score is more than 5 or Wong Baker pain scale more than 4 postoperatively.Timepoint: Time from peritonsillar infiltration of study drugs till first rescue analgesia given postoperatively.Total number of Analgesia in 24hrs postopertively.

Secondary

MeasureTime frame
1) Total number of rescue analgesic dosages consumed in 24 hours postoperatively. 2) For the first 24 hours after surgery, the total oral intake (fluids and semisolids). 3) Perioperative side effects: such as hypotension, hypertension, tachycardia, bradycardia, hypoxia, arrhythmia, excessive secretions, bleeding, respiratory depression, nausea, and vomiting will be noted.4) Ramsay sedation scale.5) CHEOPS score and VAS score postoperatively.Timepoint: From the time of study drug administration till 24hrs postoperatively.

Countries

India

Contacts

Public ContactDr Sumedha Mehta

Smt kashibai Navale medical College and General Hospital

drsumedhamehta1@gmail.com9923091187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026