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To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical ketamine and topical bupivacaine | Active Comparator | 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound. |
|
| Caudal ketamine and caudal bupivacaine | Active Comparator | 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to first request for postoperative analgesia | time in hours from admission to PACU till first request for analgesia | 48 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| total consumption of postoperative analgesics | the amount of analgesic drugs in mg given in the first 48h postoperative | 48 hours postoperative |
| The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score |
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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 department, faculty of medicine, Assiut university, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospitals | Asyut | Assiut Governorate | 715715 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine | Drug | 0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure. |
|
|
| Bupivacaine | Drug | 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route |
|
|
| Bupivacaine | Drug | 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure |
|
|
| 180 minutes postoperative |
| Faces Legs Activity Cry Consolability tool (FLACC, 0-10). | 180 minutes postoperative. |
| the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness). | 60 minutes postoperative |
| parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor). | the score will be recorded once at the end of the study | 48 hours postoperative |
| noninvasive blood pressure | Intra-operative |
| heart rate | Intra-operative |
| Verbal Numeric Rating Scale (VNRS) | the pain score will be assessed at frequent intervals in the 1st 48 h postoperative | 48 hours postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |