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OpenTrials
Completed

NCT Number: NCT04445636

Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.

The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.

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Key information

Conditions

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 11562, Egypt

About this study

The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I, II, III.
  • Patients undergoing lung cyst excision.
  • Patients undergoing Patent Ductus Arteriosus ligation.

Exclusion criteria

  • Preoperative mechanical ventilation.
  • Preoperative inotropic support
  • History of mental retardation or delayed development that may interfere with pain intensity assessment
  • Known or suspected coagulopathy,
  • Any congenital anomalies of the sacrum or any infection at the site of injection.
  • Known or suspected allergy to any of the studied drugs.

Treatment and study plan

Dexmedetomidine

Drug

Caudal block with Dexametomedine as an adjuvant to bupivacaine.

Other names: Precedex

Morphine

Drug

Addition of morphine as adjuvant to bupivacaine during caudal block.

Primary outcomes

  1. Duration of postoperative analgesia in hours.

    Time frame: 3 months

    Duration of postoperative analgesia in hours.

Secondary outcomes

  1. Opioid consumption in the first 24 hours post- operative.

    Time frame: 3 months

    Opioid consumption in the first 24 hours post- operative.

  2. The duration of ICU stay in days

    Time frame: 3 months

    The duration of ICU stay in days

  3. Pain score FLACC from 0 to 6

    Time frame: 3 months

    Pain score FLACC from 0 to 6

  4. Post operative heart rate

    Time frame: 3 months

    Postoperative heart rate in beat per minute

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Dec 22, 2020

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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