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OpenTrials
Completed

NCT Number: NCT01661803

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with known sensitivity to drugs to be used.
  • gross spinal deformity
  • patients in whom regional anesthesia is contraindicated.
  • patients with peripheral neuropathy.
  • patient with hemodynamic instability.

Sponsors and collaborators

Lead sponsor

ACPM Medical College

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.