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A Clinical Trial To Study The Effects Of Injection Ketamine-Dexmedetomidine Combination For Sedation In Children during operations of hand Under Nerve Block.

To Compare The Effect Of Ketamine-Dexmedetomidine (KETODEX) Combination When Given Either As Continuous Infusion Or Intermittent Boluses For Perioperative Sedation In Children Undergoing Upper Limb Orthopedic Surgeries Under Supraclavicular Brachial Plexus Block- A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047798
Enrollment
36
Registered
2022-11-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Injection ketamine and dexmedetomidine combination: For upper limb surgeries to be performed under supraclavicular brachial plexus block in children, perioperative sedation will be prov

Sponsors

Bharati Vidyapeeth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA Grade I or Grade II patients 2.Either sex 3.Aged 2 to 8 years 4.Scheduled for elective upper limb orthopedic surgeries under USG guided supraclavicular brachial plexus block.

Exclusion criteria

Exclusion criteria: 1.Parents not consented to participate in the study 2.Known allergy to dexmedetomidine and ketamine 3.Known systemic disorder

Design outcomes

Primary

MeasureTime frame
To compare the intraoperative sedation scores [UMSS score] of two groups of inj. ketamine-dexmedetomidine combination [Inj.KETODEX] when given either as continuous infusion or intermittent boluses.Timepoint: Assessment of perioperative sedation scores [UMSS] - for 120 minutes.—

Secondary

MeasureTime frame
1.Total intraoperative consumption of injection dexmedetomidine and ketamine. 2.Awakening time [time to attain UMSS less than 1 after stopping drug infusion at the end of surgery]. 3.Recovery or discharge time [time to attain a modified Aldrete score more than 9 after transfer to recovery] . 4.Adverse effects of study drugs.Timepoint: 1.Total intraoperative consumption of injection dexmedetomidine and ketamine- for the duration of surgery. 2.Awakening time- for 30 minutes. 3.Recovery or discharge time-for 90 minutes postoperatively 4.Adverse effects of study drugs- upto 120 minutes postoperatively.—

Countries

India

Contacts

Public ContactPrashant Lomate

Medical college

drprashantlomate@gmail.com02332212780

Outcome results

None listed

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