Efficacy of a low dose of iv ketamine vs caudal epidural with bupivacaine(Local Anaesthetic) for pain relif in children undergoing surgery under general anesthesia

Completed

Conditions: Inguinal hernia, operative patient, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,

Registration Number: CTRI/2018/02/011822

Lead Sponsor: All India Institute of Medical Science Bhubaneswar

Brief Summary: caudal epidural block has been commonly used in pediatric postoperative pain management in children undergoing lower abdominal surgeries. However, apart from procedural failure, there is the possible risk of accidental dural puncture, infection etc. Moreover, in children with coagulopathy and infection, it is contraindicated.

Ketamin, an NMDA - receptor antagonist is commonly used in pediatrics, at subanaesthetic IV doses(less than equal to 0.3mg/kg) possesses a centrally mediated analgesic properties, without increasing the risk of side effects seen with normal doses. Numerous clinical studies support the role of subanaesthetic doses of ketamine in acute pain settings. there are also very few studies comparing the efficacy of subanesthetic doses of ketamine vs caudal epidural in pediatrics.

Hence, this study was undertaken to determine the efficacy of subanaesthetic doses of IV ketamine (0.3mg/kg) vs caudal epidural with 1ml /kg of 0.125%bupivacain in children undergoing inguinoscrotal surgeries.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 144

Inclusion Criteria

children below 6yr and above 2 month posted for elective inguinoscrotal or lower limb surgery.

Exclusion Criteria

children with contraindication to caudal anesthesia, or those with cardiovascular diseases, anaemia, known drug allergy to ketamine or bupivacaine, children with clotting disorders, or those whose parents/guardians refuse to provide consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify, the efficacy of sub-anesthetic dose of ketamine (0.30 mg/kg) compared to caudal bupivacaine (0.125%, 1ml/kg) for post op analgesia in pediatric patient. The response to pain is defined as FLACC score less than or equal to four immediately after surgery.	post operative
The primary outcome of this study is to measure the proportion of patients achieving the response in each group.	post operative

Secondary Outcome Measures

Name	Time	Method
Difference in inflammatory markers (IL6 and TNF Î±) between two groups.

Trial Locations

Locations (1): All India Institute of Medical Science, Bhubaneswar.
🇮🇳
Khordha, ORISSA, India
All India Institute of Medical Science, Bhubaneswar.
🇮🇳Khordha, ORISSA, India
Dr Alok Kumar Sahoo
Principal investigator
9438884160
alokks108@gmail.com