Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .

NCT ID: NCT05688371

Last Updated: 2024-09-25

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-10-01

Brief Summary

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The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults

Detailed Description

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Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.

Conditions

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PCA Children Dexmedetomidine Morphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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standard dose morphine

children will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion

Group Type ACTIVE_COMPARATOR

standard dose morphine

Intervention Type DRUG

Receiving 0.05 mg morphine/kg as a bolus.

low dose morphine and dexmedetomidine

children will receive 0.02 mg morphine /kg bolus dose plus 0.2 µg/kg dexmedetomidine dissolved in 50 ml normal saline and10 microgram/kg continuous infusion .

Group Type ACTIVE_COMPARATOR

low dose morphine plus dexmedetomidine

Intervention Type DRUG

Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine

Interventions

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standard dose morphine

Receiving 0.05 mg morphine/kg as a bolus.

Intervention Type DRUG

low dose morphine plus dexmedetomidine

Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine

Intervention Type DRUG

Other Intervention Names

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morphine sulphate precedex

Eligibility Criteria

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Inclusion Criteria

1. ASA I \& II of both sex.
2. Age between 8 and 12 years.
3. Patients scheduled for exploration surgery under general anesthesia.

Exclusion Criteria

1. Parents refused to give consent.
2. Patients with history of allergy to morphine or dexmedetomidine.
3. Mental disorders.
4. Unsuitability for extubation.
5. Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
6. children with chronic opioid use for \> 3 monthes
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Mariana Soliman

Benisuef university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana abdelsayed Mansour, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Benisuef university hospital

Locations

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Benisuef University Hospital

Egypt, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mariana abdelsayed Mansour, MD

Role: CONTACT

01222960009

Facility Contacts

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Mariana AbdElsayed Mansour, MD

Role: primary

01222960009

Other Identifiers

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Mariana AbdElsayed Mansour

Identifier Type: -

Identifier Source: org_study_id

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