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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445636
• Other study ID #: N239-2020
• Status: Completed
• Phase: N/A
• Start date: June 28, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 10, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Dexmedetomidine
Caudal block with Dexametomedine as an adjuvant to bupivacaine.
• Morphine
Addition of morphine as adjuvant to bupivacaine during caudal block.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835. — View Citation

El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677. — View Citation

Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia in hours.	Duration of postoperative analgesia in hours.	3 months
Secondary	Opioid consumption in the first 24 hours post- operative.	Opioid consumption in the first 24 hours post- operative.	3 months
Secondary	The duration of ICU stay in days	The duration of ICU stay in days	3 months
Secondary	Pain score FLACC from 0 to 6	Pain score FLACC from 0 to 6	3 months
Secondary	Post operative heart rate	Postoperative heart rate in beat per minute	3 months