Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection

NCT ID: NCT05639777

Last Updated: 2022-12-07

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-05-15

Brief Summary

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The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.

Detailed Description

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Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).

Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.

Conditions

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Dexmedetomidine Adenotonsillectomy Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intranasal

That will receive intranasal dexmedetomidine (1.5mcg/kg)

Group Type EXPERIMENTAL

Dexmedetomidine group

Intervention Type DRUG

That will receive intranasal dexmedetomidine (1.5mcg/kg)

control group

That will receive the same volume of 2 ml of intranasal normal saline

Group Type PLACEBO_COMPARATOR

control group

Intervention Type OTHER

That will receive the same volume of 2 ml of intranasal normal saline

Interventions

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Dexmedetomidine group

That will receive intranasal dexmedetomidine (1.5mcg/kg)

Intervention Type DRUG

control group

That will receive the same volume of 2 ml of intranasal normal saline

Intervention Type OTHER

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

1. Children with recent mild URI or asthma.
2. aged from 3 to 10 years
3. ASA Physical Status II,
4. undergoing adenotonsillectomy

Exclusion Criteria

1. Parental refusal of participation
2. Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
3. Lower respiratory tract infection
4. Congenital heart diseases
5. Known hypersensitivity to specific anesthetic agent
6. Liver or renal disease
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Eman Ahmed Azzam

Resident of Anesthesia, Surgical Intensive Care and Pain Mrdicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman A Yousef, Professor

Role: PRINCIPAL_INVESTIGATOR

Anesthiology' Surgical Intensive care and Pain Medicine

Gehan M Eid, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine

Wail E Messbah, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Anesthiology' Surgical Intensive care and Pain Medicine

Locations

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Eman Ahmed Azzam

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman A Azzam, M․B․B․CH

Role: CONTACT

0020103743150

Facility Contacts

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Eman A Azzam, MD

Role: primary

0020103743150 ext. 139

Other Identifiers

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35355/3/22

Identifier Type: -

Identifier Source: org_study_id

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