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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Anesthesia, Local

Treatments

Drug: Morphine
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04445636
N239-2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

Dexmedetomidine group
Experimental group
Description:
A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.
Treatment:
Drug: Dexmedetomidine
Morphine group
Experimental group
Description:
A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.
Treatment:
Drug: Morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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