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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

Efficacy of a sub-anesthetic dose of iv ketamine vs caudal epidural with bupivacaine for analgesia in children undergoing inguinoscrotal and lower extremity surgery under general anesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011822
Enrollment
144
Registered
2018-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K40- Inguinal hernia Health Condition 2: null- operative patient Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 4: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Group -K: will receive a sub-anesthetic dose of ketamine (0.3mg/kg) along with GA Control Intervention1: Group C: will be given 1 ml/kg of 0.125% bupivacaine through the caudal route

Sponsors

All India Institute of Medical Science Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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. The primary outcome of this study is to measure the proportion of patients achieving the response in each group. Timepoint: post operative

Secondary

MeasureTime frame
Difference in inflammatory markers (IL6 and TNF �±) between two groups. - intra operative analgesic requirement time to extubation, difference in PONV, difference in sedation scores, incidence of emergence delirium Timepoint: 1 yr

Countries

India

Contacts

Public ContactDr Alok Kumar Sahoo

All India Institute of Medical Science, Bhubaneswar.

alokks108@gmail.com9438884160

Outcome results

None listed

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