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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.

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
NameTimeMethod
Duration of analgesia assessed by Modified Objective Pain Score greater than 410minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours
Secondary Outcome Measures
NameTimeMethod
Emergence timeTime from end of surgery to opening of eyes spontaneously or on calling.
Duration of motor blockFrom time of block to time of spontaneous leg movements
Sedation using Simple sedation score10minute 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, SpO2Intraoperatively, 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, India
Dr Alvi Vinod
Principal investigator
8281377694
alvivinod123@gmail.com

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