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

ACPM Medical College

Status: Completed

Conditions: Pediatric Spinal Anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT01661803

acpm anesthesia.dhule.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

group-A and group-B

Description:

Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \>15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \>15 with 1 mcg/kg preservative free clonidine).

group-A and group--B

Description:

Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \>15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \>15 with 1 mcg/kg preservative free clonidine).