Ketamine for pain relief via different routes in children aged 2-6years.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/07/055105
• Lead Sponsor: Indira Gandhi medical college and hospital

Brief Summary

Caudal block is commonly performed for postoperative pain management in children undergoing abdominal and lower limb surgeries. Although it has its own contraindications and benefits. Ketamine in subanaesthetic doses possesses centrally mediated analgesic properties with minimal effects on consciousness and cognition of the patient.

However whether IV Subanaesthetic ketamine or caudal ketamine provides a level of postoperative analgesia that is similar to caudal bupivacaine in children is unknown.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-19
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The study will be carried out in 70 patients in age group of 2years- 6years.

Exclusion Criteria

• 1.Refusal for consent by parents/ guardian.
• 2.Children with cardiovascular diseases.
• Any history of bleeding or clotting disorder.
• Local infection at the site of needle insertion.
• History of allergy to local anaesthetics of ketamine.
• Children with coagulopathy, pilonidal sinus or local site infections.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare duration of prospective pain free period in paediatric patients following administration of subanaesthetic doses of intravenous ketamibe plus caudal bupivacaine to caudal bupivacaine plus ketamine	24hrs

Secondary Outcome Measures

Name	Time	Method
To measure the duration of pain free period & amount of analgesic consumption in first 24hrs postoperatively	24hrs
To evaluate requirement of rescue analgesia postoperatively	24hrs
Secondary outcome in form of postoperative agitation, sedation etc.	24hrs

Trial Locations

Locations (1)

Indira Gandhi medical college andhospital shimla; 🇮🇳 Shimla, HIMACHAL PRADESH, India

Indira Gandhi medical college andhospital shimla

🇮🇳Shimla, HIMACHAL PRADESH, India

Dr Divya garg

Principal investigator

08219309970

gargdivyagarg8@gmail.com