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

Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study

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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation; Postoperative Analgesia
• Intervention / Treatment: Drug: Ketamine

Detailed Description

Preoperative communication, premedication interventions, and being accompanied by parents are useful methods in decreasing preoperative separation anxiety , postoperative psychological trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.

Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of decreasing awareness, pain, and memory that allowing patient continue his ,or her own protective reflexes, and moving purposefully( O' Donnell etal, 2003).

Ketamine is an anesthetic drug having sedative, and analgesic properties with different routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal, sublingual, intranasal, and nebulized) .

Ketamine produces its analgesic properties in acut pain management from reversible antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors, nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.

The oral route is the most popular than other routes ,as it's safe, efficient, acceptable, and familiar for pediatric patients..

Oral ketamine often requires higher, and frequent doses as it's bioavailability is lower (17-24%) compared to IV (100%),Intramuscular (93%), sublingual/transbuccal(30%), intranasal(25-50%),and inhaler (70%) due to extensive first pass metabolism in liver, and intestine.

Ketamine inhalation is safe, rapid absorption, and affordable route of administration.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 055
    • Zagazig University Hospitsals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral ketamine; evaluate sedative,and analgesic effects	Drug: Ketamine; evaluate sedative, and analgesic effects of oral or nebulized ketamine; Other Names: ketalar
Active Comparator: nebulized ketamine; evaluate sedative, and analgesic effects	Drug: Ketamine; evaluate sedative, and analgesic effects of oral or nebulized ketamine; Other Names: ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Rarely awake, needs shaking, or shouting to wake up.; Asleep, eyes closed, wake up when called softly,or lightly touched.; Sleepy, but eyes open spontaneously.; Awake.; 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): Calm.; Apprehensive, not smiling, tentative behavior, withdrawn.; Crying.; 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): Calm.; Apprehensive, not smiling, tentative behavior, withdrawn.; Crying.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare the intensity of pain postoperative.	the intensity of pain will be assessed using modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Score 1 2 3 Cry No cry Crying, moaning Scream Facial Smiling Composed Grimace Verbal Positive None, or other complaints Pain complaint Torso Neutral Shifting, tense, upright Restrained Leg Neutral kicks, squirm, drawn up Restrained Touch No touching Reach, touch, grab Restrained CHEOPS pain score=SUM(0)(points for all 6 parameters). Interpretation : minimum score:6, maximum score:18.	immediately after recovery, and every half hour for four hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ketamine; sedation; analgesia; pre-schoolers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 5296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No