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

NCT04445636 | Completed

• 1 other identifier: N239-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

thoracic surgeries; pediatric caudal; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia in hours.

  Duration of postoperative analgesia in hours.

  3 months

Secondary Outcomes (4)

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

  3 months

• The duration of ICU stay in days

  3 months

• Pain score FLACC from 0 to 6

  3 months

• Post operative heart rate

  3 months

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.

Drug: Dexmedetomidine

Morphine group

EXPERIMENTAL

A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.

Drug: Morphine

Interventions

Dexmedetomidine DRUG

Caudal block with Dexametomedine as an adjuvant to bupivacaine.

Also known as: Precedex

Dexmedetomidine group

Morphine DRUG

Addition of morphine as adjuvant to bupivacaine during caudal block.

Morphine group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 11562, Egypt

Location

Related 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.

  PMID: 22013248 BACKGROUND

• 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.

  PMID: 24843324 BACKGROUND

• 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.

  PMID: 27550555 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Morphine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• AHMED ISMAIL, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be achieved by a statistician 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: June 28, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 10, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)