Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Clonidine (OC).
- Who it may be relevant to
- Registry conditions: Pediatric Sedation, Clonidine Sedation, Ketamine Sedation. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Detailed description
Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.
Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.
Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.
Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.
Interventions
- Drug Oral Clonidine (OC)
compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Primary outcome measures
- Sedation level [Time frame: 60 minutes after administration of the drug (at time of separation from the parents).]
Secondary outcome measures (2)
- Fentanyl administration. [Time frame: at 10, 20, 30, 40, 50 minutes until the end of the surgery]
- Postoperative emergence delirium [Time frame: Postoperative at 15, 30, 45 and 60 minutes]
Eligibility criteria
Inclusion criteria
- Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
- ASA I and II
Exclusion criteria
- Parents refusal.
- ASA risk score >II
- Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
- Allergy from the used drugs.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Faculty of Medicine, Cairo University — Cairo
Identifiers
NCT: NCT07461376 · Pediatric Sedation