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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01661803
Enrollment
60
Registered
2012-08-10
Start date
2009-11-30
Completion date
2012-01-31
Last updated
2012-08-10

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

Conditions

Pediatric Spinal Anesthesia

Keywords

bupivacaine, clonidine, pediatric spinal, efficacy, duration, quality, side effects, intrathecal bupivacaine alone, bupivacaine plus clonidine

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.

Interventions

None listed

Sponsors

ACPM Medical College
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026