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To determine the difference in MEAN TIME DURATION FOR THE NEED OF FIRST RESCUE ANALGESIA AMONG THE TWO GROUPS.

Comparison of Analgesic effect of Dexmedetomidine versus Tramadol as adjuvants to caudal Ropivacaine in infraumblical surgeries in pediatric patients-: A Randomized, Double Blind, interventional Study at SMS Medical College and Attached Group of Hospitals Jaipur during 2020-21

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030958
Enrollment
60
Registered
2021-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Injection Dexmedetomidine 2 microgram/kg: Injection Dexmedetomidine 2 microgram/kg (volume 0.5ml) with 0.2% Ropivacaine 1 ml/kg. Control Intervention1: Injection Tramadol 2mg/kg: Injec

Sponsors

Sawai Man Singh Medical College And Attached Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children undergoing elective infraumblical surgery 2.Age ranging between 1-7 years of either sex. 3.ASA grade I&II. 4.Children weight between 7 to 25 kg.

Exclusion criteria

Exclusion criteria: 1.History of allergic reactions to drugs used in study. 2.Patients on anticoagulant therapy and H/O coagulation disorders. 3.Local infection at the proposed site of puncture for caudal anaesthesia. 4.Lack of consent by parents/guardian 5.History of developmental delay. 6.History of neurological deficit or vertebral deformity.

Design outcomes

Primary

MeasureTime frame
To determine the difference in mean time duration for the need of first rescue analgesia among the two groups. Timepoint: 24 HOURS—

Secondary

MeasureTime frame
1.To assess and compare Hemodynamic changes: -HR, MBP, SBP and DBP. 2.Difference in mean CHEOPS Score at different time intervals. 3.Difference in mean Ramsay Sedation Score at different time intervals. 4.Difference in mean Modified Bromage scale at different time intervals. 5.Complication if any. Timepoint: 24 HOURS—

Countries

India

Contacts

Public ContactDr Bajrang Lal Yadav

SMS Medical college ,Jaipur

pratibha.rathore3@gmail.com8079043844

Outcome results

None listed

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