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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Oral Clonidine (OC) | Active Comparator | This group of children will be premedicated with oral clonidine (4 mic/Kg) 60 minutes preoperatively in a sip of water. |
|
| Group Oral Ketamine (OK) | Active Comparator | This group of children will be premedicated with oral Ketamine (10 mg/Kg) 60 minutes preoperatively in a sip of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Clonidine (OC) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation level | using Ramsey sedation scale (RSS) | 60 minutes after administration of the drug (at time of separation from the parents). |
| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl administration. | Need and timing of fentanyl administration intraoperatively. | at 10, 20, 30, 40, 50 minutes until the end of the surgery |
| Postoperative emergence delirium | assessed at PACU every 15 minutes for 1 hour using pediatric anesthesia emergency and delirium scale (PAED). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omnia Y Kamel, Doctorate degree | Contact | 01270130326 | omniayehiakamel90@gmail.com | |
| Ahmed O Mohamed, Master | Contact | 01014429299 | ahmedomoh630@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nevine M Gouda, Professor | Cairo University | Study Chair |
| Sherif M Soaida, Assistant Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo University | Recruiting | Cairo | Giza Governorate | Egypt |
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A randomized controlled double blinded study
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● Patients will be randomized using a computer-generated randomization list. Random group assigned will be enclosed in a sealed envelope to ensure concealment of allocation sequence. The sealed envelope will be opened by an anesthesiologist who will not be involved in the study to prepare the drug solution according to randomization. The anesthesiologist administrating the drug and observing the patient will be blinded to the treatment group.
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| Postoperative at 15, 30, 45 and 60 minutes |
| ID | Term |
|---|---|
| D003000 | Clonidine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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