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Comparison of two drugs added to local anaesthetic for pain relief in children undergoing cleft palate surgeries.

Comparative Evaluation of dexmedetomidine versus dexamethasone as an adjuvant to bupivacaine in bilateral suprazygomatic maxillary nerve block for postoperative analgesia in children undergoing cleft palate surgeries : A Randomized, Prospective, Double-Blind Study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097174
Enrollment
60
Registered
2025-11-11
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: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities

Interventions

Intervention1: Group DX: will receive 1-2 mL of a solution containing 0.15 mL /kg of 0.25% bupivacaine with 0.5 µg /kg of dexmedetomidine on each side Control Intervention1: Group DM: will receive 1-2

Sponsors

AIIMS New Delhi
Lead Sponsor
AIIMS New Delhi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children posted for elective cleft palate repair under general anaesthesia Aged between 8 months to 5 years ASA category I and II Willing to give consent

Exclusion criteria

Exclusion criteria: Lack of Parental consent Allergic to local anesthetics Coagulation disorders Local infection or lesion at the proposed puncture site Language difficulties Cognitive disorders Comorbid conditions like congenital heart diseases airway obstruction disease and central nervous system disorders

Design outcomes

Primary

MeasureTime frame
Time for first rescue analgesia Duration of analgesia Timepoint: Time for first rescue analgesia 24 hours duration of analgesia 24 hours

Secondary

MeasureTime frame
Postoperative FLACC score Total Postoperative fentanyl consumption Parental satisfaction scale (LIKERT) Intraoperative & total opioid useTimepoint: 4HRS 8HRS 16HRS 20HRS 24HRS

Countries

India

Contacts

Public ContactAmanpreet Singh

AIIMS New Delhi

drsinghsneha@gmail.com9919625952

Outcome results

None listed

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