A Comparative Evaluation of Nebulized Dexmedetomidine and Nebulized Ketamine as a Premedication in Pediatric Surgeries

NCT05719506 | Completed Phase 4

• 1 other identifier: 34717/5/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

preoperative anxiety and parental deprivation can be a traumatic time for young children undergoing surgery and remain challenges to anesthesiologists. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia

Conditions

Anesthesia Refusal

Outcome Measures

Primary Outcomes (1)

• the sedating effects of these drugs .

  the sedating effects of these drugs using Ramsay sedation scale as a premedications. Our target score (2 or 3 or 4) on the other side score 1 failure of sedation and score 5 or 6 over sedation. Table :Ramsay sedation scale 1. Anxious and agitated, restless, or both. 2. Cooperative, oriented, and calm. 3. Responsive to commands only. 4. Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5. Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6. Unresponsive.

  30 minutes

Secondary Outcomes (1)

• ease of parental separation

  30 minutes

Study Arms (3)

control group 1

SHAM COMPARATOR

control group (nebulized normal saline without drug: group C) .The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR.

Other: normal saline without drug

dexmedetomidine group 2

EXPERIMENTAL

that receive nebulized dexmedetomidine (3 μg/kg; group D),The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR. Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded.

Drug: Dexmedetomidine

ketamine group 3

EXPERIMENTAL

nebulized ketamine (3mg/kg; group K) ,The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR. Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded.

Drug: Ketamine

Interventions

normal saline without drug OTHER

nebulizer session with normal saline only preoperative

Also known as: control

control group 1

Dexmedetomidine DRUG

nebulizer session with dexmedetomidine preoperative

Also known as: precedex

dexmedetomidine group 2

Ketamine DRUG

nebulizer session with ketamine preoperative

Also known as: katalar

ketamine group 3

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The children included in this study:
• Will be of either gender.
• Age between 3 and 10 years.
• Belonging to American Society of Anesthesiologists (ASA) I, II physical status.
• Undergoing elective surgery ranging in time between 30 - 90 minutes under general anesthesia.

You may not qualify if:

• Parental refusal of participation.
• Chest infection or respiratory distress.
• Cardiac disease.
• Mental or physical disability.
• Treatment with sedatives or anticonvulsants.
• Allergy to drugs or their ingredients.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Tanta University Hospitals

Tanta, 31511, Egypt

Location

Tanta University

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Treatment Refusal

Interventions

Saline Solution; Pharmaceutical Preparations; Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alaa Abo Hagar, M.D Lecturer of Anesthesia and Intensive Care,

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 9, 2023
• Study Start: July 21, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)