Finding the Best Dose of a Sedative i.e. Dexmedetomidine Added to a Numbing Medicine i.e. Ropivacaine for Pain Relief in Children After Surgery by caudal block technique: A Controlled Study

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/05/086263
• Lead Sponsor: Rajendra Institute of Medical Sciences

Brief Summary

Pediatric patients require specific attention when it comes to postoperative analgesia and  caudal block as a central nerve block technique, is one of the common methods performed to  manage perioperative pain in pediatric lower abdominal and perineal surgeries. Local  anesthetics have usually been the main drug in such cases, and if administered alone in the  caudal blockade, they do not usually provide prolonged analgesia. Ropivacaine is one of the most common drugs in this group. The addition of dexmedetomidine to local anesthetics or its administration as  an adjunct for pain management in a variety of techniques enhances their effects. This study will be carried out to compare the efficacy of ropivacaine with different doses of  dexmedetomidine in caudal block for pediatric lower abdominal and perineal surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-02-05
• Study Start: 2025-05-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Assessed patients of ASA physical status I and II.
• Normal biochemical and hematological parameters.
• Age group between 2-6 years.
• Lower abdominal and perineal surgeries, lasting one to three hours under general anaesthesia f.
• Informed written conset from legal guardian.

Exclusion Criteria

• Parent/legal guardian not willing b.
• Sacral abnormalities c.
• Patients with coagulopathies d.
• History of allergy to study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To record the time of requirement of first rescue	Visual Analogue Scale Score | Just after extubation | 1hours post surgery | 2hours post surgery | 6hours post surgery | 12hours post surgery | 24hours post surgery
analgesic	Visual Analogue Scale Score | Just after extubation | 1hours post surgery | 2hours post surgery | 6hours post surgery | 12hours post surgery | 24hours post surgery

Secondary Outcome Measures

Name	Time	Method
a) To record the hemodynamic parameters systolic blood pressure, diastolic blood pressure, heart rate and MAP	b) To record incidence of adverse effects i.e. hypotension, bradycardia and sedation

Trial Locations

Locations (1)

Rajendra Institute of Medical Sciences; 🇮🇳 Ranchi, JHARKHAND, India

Rajendra Institute of Medical Sciences

🇮🇳Ranchi, JHARKHAND, India

Dr Naresh Kumar Murmu

Principal investigator

9905832269

nkumar1416@gmail.com