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Completed

NCT Number: NCT02037802

Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery

pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 3-12 years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

Exclusion criteria

  • known allergy to bupivacaine
  • inflammation at caudal area
  • spinal cord deformity

Treatment and study plan

B-Braun, Perifix® ONE Paed, Germany

Device

caudal epidural catheterization bupivacaine fentanyl

Pethidine

Drug

pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia

Propofol

Drug

fentanyl propofol atracurium besylate

Bupivacaine

Drug

Fentanyl

Drug

Primary outcomes

  1. Intraoperative blood pressure

    Time frame: from the induction of anesthesia till end of surgery at half an hour intervals

    measure systolic and diastolic blood pressure

Secondary outcomes

  1. postoperative blood pressure

    Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

    record systolic and diastolic blood pressure every hour for the first 24 hours postoperative

  2. intraoperative central venous pressure

    Time frame: fromom the induction of anesthesia till end of surgery at half an hour intervals

  3. postoperative heart rate

    Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

  4. postoperative central venous pressure

    Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

  5. intraoperative heart rate

    Time frame: from the induction of anesthesia till end of surgery at half an hour intervals

Other outcomes

  1. pain scoring system (objective behavioural pain score)

    Time frame: from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2014
Registry last updated
Oct 6, 2014

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.

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