A comparative clinical study of sedative effects of intravenous and intramuscular Ketamin in pediatric patients

Comparison of sedation with intravenous and intramuscular Ketamin in children admitted to the emergency department: a Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014071218454N1

Enrollment

240

Registered

2014-12-30

Start date

2014-03-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia. Dissociative anesthesia

Interventions

Intervention 1: Patients in control group will recieve Ketamine 1.5 ml / kg before procedures via intravenous infusion. Intervention 2: In the intervention group the patients will receive intera musc

Treatment - Drugs

Patients in control group will recieve Ketamine 1.5 ml / kg before procedures via intravenous infusion

In the intervention group the patients will receive intera muscular Ketamine at a dose of 4 ml / kg once before procedures

Eligibility

Sex/Gender

All

Age

3 Months to 15 Years

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: Age three months to 15 years and had to undergo short and painful emergency procedures. EXCLUSION CRITERIA: Subjects with a history of allergy to Ketamine; severe cardiovascular diseases; thyroid disorder; head injury; CNS disorders; glaucoma or acute globe injuries; and history or evidence of psychosis; obstructive sleep apnea; active pulmonary disease; tracheal stenosis or surgery; children needing procedures associated with stimulation of posterior pharyngeal region and not willing to participate

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation efficacy. Timepoint: During intervention. Method of measurement: Efficacy of medicine in pain management and sedation as excellent (full sedation, immobility, and analgesia during the whole procedure), moderate (slight movements due to pain without interfering to procedure), and poor (movements associated with pain that interfered in the procedure).;Respiratory Adverse Events. Timepoint: During intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of administration of the drug until hospital discharge.;Procedure time. Timepoint: During intervention. Method of measurement: From the begining of sedatiion till emergency discharge.	—

Measure

Time frame

Sedation efficacy. Timepoint: During intervention. Method of measurement: Efficacy of medicine in pain management and sedation as excellent (full sedation, immobility, and analgesia during the whole procedure), moderate (slight movements due to pain without interfering to procedure), and poor (movements associated with pain that interfered in the procedure).;Respiratory Adverse Events. Timepoint: During intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of administration of the drug until hospital discharge.;Procedure time. Timepoint: During intervention. Method of measurement: From the begining of sedatiion till emergency discharge.

—

Secondary

Measure	Time frame
Non respiratory adverse events. Timepoint: During intervention. Method of measurement: Dysphoria, Vomiting, Myoclonus, Nausea, Stiffness, Rash, Seizures, Restlessness.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnaz Borouman Rezazade

Mashhad University of Medical Sciences

dr.boroumand@hotmail.com+98 51 3852 5312

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026