Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.

NCT03885427 | Completed Early Phase 1 DMC

• 1 other identifier: 5296
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.

Conditions

Conscious Sedation; Postoperative Analgesia

Keywords

sedation; ketamine; analgesia; pre-schoolers

Outcome Measures

Primary Outcomes (3)

• evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery

  • To assess onset time of sedation by sedation scale (SS-5) score. The sedation scale: 1. Rarely awake, needs shaking, or shouting to wake up. 2. Asleep, eyes closed, wake up when called softly,or lightly touched. 3. Sleepy, but eyes open spontaneously. 4. Awake. 5. Agitated.

  30 minutes.

• compare each sedation technique for the time of separation state.

  The separation state will be assessed and designated as satisfactory separation if the Emotional State Scale (ESS-4) score will be no more than two points. The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.

  at 30 minutes after drug intake

• compare the sedation technique for successful venous cannulation.

  Successful venous cannulation is defined as an Emotional State Scale (ESS-4≤ 2). The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.

  at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt.

Secondary Outcomes (1)

• to compare the intensity of pain postoperative.

  immediately after recovery, and every half hour for four hours postoperative

Study Arms (2)

oral ketamine

EXPERIMENTAL

evaluate sedative,and analgesic effects

Drug: Ketamine

nebulized ketamine

ACTIVE COMPARATOR

evaluate sedative, and analgesic effects

Drug: Ketamine

Interventions

Ketamine DRUG

evaluate sedative, and analgesic effects of oral or nebulized ketamine

Also known as: ketalar

nebulized ketamine; oral ketamine

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents acceptance.
• Age (3-6) years old.
• American Society of Anesthesiologist physical status (ASA) I / II
• Elective surgery of approximately half to one hour duration under general anesthesia.
• Child With Body Mass Index (BMI) (15-18kg/m²)

You may not qualify if:

• Parents refusal.
• Altered mental status, and epilepsy.
• History of allergy to ketamine.
• Recent respiratory tract infection.
• Sever dysfunction of the central nervous system.
• Increased intracranial pressure, and increased intra-ocular pressure.
• Cardiac dysrhythmia ,and/or congenital heart disease.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitsals

Zagazig, 055, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alshaimaa Kamel, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator will prepare the drug, and the out come assessor(the anesthesiologist not sharing in the study) will assess the primary, and secondary outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: this will be a double blind study, and utilize a convenience sample of pre-schoolers. 31 children recruited in In oral ketamine arm, and 31 children in nebulized ketamine arm

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 21, 2019
• Study Start: March 27, 2019
• Primary Completion: May 15, 2019
• Study Completion: June 1, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

EG (1)