Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation

Completed

• Conditions: Pediatric Spinal Anesthesia

• Registration Number: NCT01661803
• Lead Sponsor: ACPM Medical College

Brief Summary

The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.

Detailed Description

In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.

American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.

Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.

The patients studied across the group did not vary much with respect to age, weight and sex distribution.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-04
• Study First Submitted QC: 2012-08-09
• Last Update Submitted: 2012-08-09
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ASA grade-1 physical status.
2. weight 5-35kg
3. age-3 to 10 yrs

Exclusion Criteria

1. patients with known sensitivity to drugs to be used.
2. gross spinal deformity
3. patients in whom regional anesthesia is contraindicated.
4. patients with peripheral neuropathy.
5. patient with hemodynamic instability.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified