Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations

Detailed Description
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In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.

Official Title
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Topical Ketamine by Neubulization Method in Tonsillectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Intravenous ketamine0.5mg/kg
* Drug: Nebulized Ketamine 1mg/kg
* Drug: Nebulized Ketamine 2mg/kg
* Drug: saline placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study Exclusion Criteria: patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous ketamine0.5mg/kg<br>intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery. | Drug: Intravenous ketamine0.5mg/kg<br>* Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.<br>* Other names: Katalar;|
| Active Comparator: Nebulized ketamine 1mg/kg<br>nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia. | Drug: Nebulized Ketamine 1mg/kg<br>* Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.<br>* Other names: Katalar;|
| Active Comparator: Nebulized ketamine 2mg/kg<br>nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia. | Drug: Nebulized Ketamine 2mg/kg<br>* Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.<br>* Other names: Katalar;|
| Placebo Comparator: control group<br>control group received placebo nebulization | Drug: saline placebo<br>* Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic consumption | The total amount of analgesics used in the first 24h postoperative in mg. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Pain intensity will be assessed postoperatively by using the Verbal Rating scale (VRS) (0 =no pain, 1 =mild pain, 2 =moderate pain, 3 =severe pain, and lastly 4 =excruciating pain). VRS assessments were performed at rest in the following time points; at arrival to PACU, 30 min, 1, 2, 3, 4, 5, 6, 12, and 24 h postoperative. - - . | 24 hours postoperative | 
| Ketamine serum levels to exclude systemic absorption of topical ketamine. | the level of ketamine in the serum. | 120 min after receiving Ketamine |