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To assess the effectiveness of adding Dexmedetomidine (a drug) to Ropivacaine (a local anaesthetic drug),compared to Ropivacaine alone, for pain relief in pediatric surgeries below the umbilicus.

To compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone for caudal epidural analgesia in pediatric infraumbilical surgeries in a tertiary care center in Kerala

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049660
Enrollment
68
Registered
2023-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Control Intervention1: Ropivacaine: 0.25% Ropivacaine (1ml/kg), single bolus dose, is given for Caudal Epidural Block, during intraoperative and postoperative period of paediatric infraumbilical surge

Sponsors

Dr Alvi Vinod
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA class 1 & 2 2. Children undergoing elective infraumbilical surgery less than 1hour duration

Exclusion criteria

Exclusion criteria: 1. Known allergy to the study drugs 2. Suspected coagulopathy 3. Infection at the site of block 4. History of developmental delay, neurological disease, skeletal deformities, cardiovascular diseases.

Design outcomes

Secondary

MeasureTime frame
Duration of motor blockTimepoint: From time of block to time of spontaneous leg movements;Emergence timeTimepoint: Time from end of surgery to opening of eyes spontaneously or on calling.;Heart rate, Mean Arterial Pressure, Respiratory rate, SpO2Timepoint: Intraoperatively, every 5minutes for the 1st half an hour and then at 10minute intervals. Postoperatively, 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours.;Sedation using Simple sedation scoreTimepoint: 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours

Primary

MeasureTime frame
Duration of analgesia assessed by Modified Objective Pain Score greater than 4Timepoint: 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours

Countries

India

Contacts

Public ContactDr Alvi Vinod

Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla

drmaryalbert@gmail.com9495685155

Outcome results

None listed

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