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

NCT ID: NCT04445636

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-28

Study Completion Date

2020-12-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia, Local

Keywords

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thoracic surgeries pediatric caudal dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Caudal block with Dexametomedine as an adjuvant to bupivacaine.

Morphine group

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

Addition of morphine as adjuvant to bupivacaine during caudal block.

Interventions

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Dexmedetomidine

Caudal block with Dexametomedine as an adjuvant to bupivacaine.

Intervention Type DRUG

Morphine

Addition of morphine as adjuvant to bupivacaine during caudal block.

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelaziz Ismail

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHMED ISMAIL, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22013248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24843324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27550555 (View on PubMed)

Other Identifiers

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N239-2020

Identifier Type: -

Identifier Source: org_study_id