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This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local ketamine group | Active Comparator | intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively. |
|
| control group | Placebo Comparator | intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively. |
|
| systemic ketamine group | Active Comparator | Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-wound instillation of ketamine | Drug | intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| total opioid consumption | the total amount of morphine consumed during follow up period | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| first request of analgesia | time to first request of rescue analgesic drug | 24 hours |
| VAS | effect of study drugs on postoperative pain measured by VAS score |
| Measure | Description | Time Frame |
|---|---|---|
| possible side effects | occurrence of possible side effects during follow up | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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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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| intra-wound instillation of normal saline | Drug | intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure |
|
|
| systemic administration of ketamine | Drug | intra-muscular administration of ketamine (1 mg/ kg), given before wound closure. |
|
| 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |