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

NCT ID: NCT03885427

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2019-06-01

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.

Conditions

Conscious Sedation; Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

oral ketamine

evaluate sedative,and analgesic effects

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

evaluate sedative, and analgesic effects of oral or nebulized ketamine

nebulized ketamine

evaluate sedative, and analgesic effects

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

evaluate sedative, and analgesic effects of oral or nebulized ketamine

Interventions

Ketamine

evaluate sedative, and analgesic effects of oral or nebulized ketamine

Intervention Type: DRUG

Other Intervention Names

ketalar

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alshaimaa Abdel Fattah Kamel

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alshaimaa Kamel, M.D

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University Hospitsals

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

5296

Identifier Type: -

Identifier Source: org_study_id