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.
Not yet recruiting
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/02/049660
- Lead Sponsor
- Dr Alvi Vinod
- Brief Summary
This study is a unicentric observational study to compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone, for caudal epidural analgesia in 68 children of 2-6years of age, belonging to ASA class 1and 2, undergoing elective infraumbilical surgery of less than 1hour duration, to be conducted in a tertiary care center in Kerala. The primary outcome will be duration of analgesia. The secondary outcomes will include duration of sedation, emergence time and duration of motor block.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- ASA class 1 & 2 2.
- Children undergoing elective infraumbilical surgery less than 1hour duration.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of analgesia assessed by Modified Objective Pain Score greater than 4 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours
- Secondary Outcome Measures
Name Time Method Emergence time Time from end of surgery to opening of eyes spontaneously or on calling. Duration of motor block From time of block to time of spontaneous leg movements Sedation using Simple sedation score 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours Heart rate, Mean Arterial Pressure, Respiratory rate, SpO2 Intraoperatively, every 5minutes for the 1st half an hour and then at 10minute intervals.
Trial Locations
- Locations (1)
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla
🇮🇳Pathanamthitta, KERALA, India
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla🇮🇳Pathanamthitta, KERALA, IndiaDr Alvi VinodPrincipal investigator8281377694alvivinod123@gmail.com