Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Ketamine
* Drug: Bupivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age (6 months to 6 years) ASA physical status I or II. Operation: elective unilateral inguinal herniotomy. Exclusion Criteria: A history of developmental delay or mental retardation, Known or suspected coagulopathy, Known allergy to any local anaesthetic, Known congenital anomaly of the spine or signs of spinal anomaly, Infection at the sacral region.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical ketamine and topical bupivacaine<br>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. | Drug: Ketamine<br>* 0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.<br>* Other names: Katalar;Drug: Bupivacaine<br>* 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route<br>* Other names: bucaine;|
| Active Comparator: Caudal ketamine and caudal bupivacaine<br>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. | Drug: Ketamine<br>* 0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.<br>* Other names: Katalar;Drug: Bupivacaine<br>* 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure<br>* Other names: bucaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal, anesthesia, analgesia, ketamine, bupivacaine