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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous ketamine0.5mg/kg | Active Comparator | intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery. |
|
| Nebulized ketamine 1mg/kg | Active Comparator | nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia. |
|
| Nebulized ketamine 2mg/kg | Active Comparator | nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia. |
|
| control group | Placebo Comparator | control group received placebo nebulization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ketamine0.5mg/kg | Drug | Intravenous ketamine 0.5mg/kg after anesthesia and before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesic consumption | The total amount of analgesics used in the first 24h postoperative in mg. | 24 hours postoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala S Abdel-Ghaffar, MD | Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospitals | Asyut | Assiut Governorate | Egypt,71571 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Nebulized Ketamine 1mg/kg | Drug | Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia. |
|
|
| Nebulized Ketamine 2mg/kg | Drug | Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia. |
|
|
| saline placebo | Drug | Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery. |
|
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| Ketamine serum levels to exclude systemic absorption of topical ketamine. | the level of ketamine in the serum. | 120 min after receiving Ketamine |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |