Clinical trial NCT03885427: Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.
Official title: Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Conscious Sedation
Postoperative Analgesia
Keywords: sedation
ketamine
analgesia
pre-schoolers
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-03-21
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery
timeFrame: 30 minutes.
measure: compare each sedation technique for the time of separation state.
timeFrame: at 30 minutes after drug intake
measure: compare the sedation technique for successful venous cannulation.
timeFrame: at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt.
Secondary outcomes:
measure: to compare the intensity of pain postoperative.
timeFrame: immediately after recovery, and every half hour for four hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitsals
Study officials:
affiliation: Zagazig University
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References: