Comparing Nebulized Ketamine,Nebulized Ketamine and Precedex and IM Ketamine for Analgesia in Pediatric Burn

NCT07086690 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: FMASU MD89/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study compares efficacy of nebulised ketamine and combination of nebulised dexmedetomidine and ketamine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries

Conditions

Inhalation Anesthesia

Outcome Measures

Primary Outcomes (1)

• Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries

  * The primary outcome will be depth of sedation evaluated by (UMSS) upon transfer to OR (after patient separation) * During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 3 mg/kg propofol as a rescue dose if vital data increased by \>20% of the baseline. Sedation will be assessed by University of Michigan Sedation Scale (UMSS) Value Patient state 0 Awake and alert Minimally sedated: tired/sleepy, appropriate response to verbal conversation, and/or sound 2 Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command 3 Deeply sedated: deep sleep, aroused only with significant physical stimulation 4 Unarousable

  5 minutes

Secondary Outcomes (1)

• Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries

  1 hour

Other Outcomes (2)

• Parental seperation anxiety scale

  10 minutes

• Recovery time

  1 hour

Study Arms (3)

Patients will receive nebulized ketamine

ACTIVE COMPARATOR

Group (1): Patients will receive nebulized ketamine (2 mg/kg) Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia.

Drug: Group (1): Patients will receive nebulized ketamine (2 mg/kg)

Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1

ACTIVE COMPARATOR

Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg) Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia.

Drug: Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg)

- Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before

ACTIVE COMPARATOR

\- Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia.

Drug: Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.

Interventions

Group (1): Patients will receive nebulized ketamine (2 mg/kg) DRUG

Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs willbe rec

Also known as: Not present

Patients will receive nebulized ketamine

Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg) DRUG

Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be re

Also known as: Nebulized ketamine and precedex

Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1

Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. DRUG

Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be re

Also known as: Not present

- Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before

Eligibility Criteria

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

You may qualify if:

• Patients of American Society of Anesthesiologists (ASA) physical status I \& II
• Pediatrics aged from 3 to 10 years.
• Both genders
• Pediatrics that has burn injuries and need sedation for cannulation and dressing.
• Burn \>5% body surface area and \<20% of surface area

You may not qualify if:

• ASA III and V patients with history of chronic illness
• Patients with known allergy/hypersensitivity to the study drug
• Congenital diseases or developmental delay or with neurological disease,
• known case of bronchial asthma or difficult airway were excluded from the study
• parents' refusal for participation in the study
• Emergency surgeries with hemodynamic instability
• mental retardation,
• neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
• treatment with anticonvulsants and sedatives
• Major sepsis or extensive infection

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Population Groups; Ketamine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marihan A Lwiz, MBBCH,M.Sc.

  Teaching assistant Ain Shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 25, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): April 16, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1/2028
• Access Criteria: Free

Locations

EG (1)