Assiut university hospitals
Asyut, Assiut Governorate, 715715, Egypt
NCT Number: NCT02462174
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
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Notify Me6 month–6 year
Male
Interventional
Phase 2 / Phase 3
Asyut, Assiut Governorate, 715715, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
Other names: Katalar
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
Other names: bucaine
Time frame: 48 hours postoperative
time in hours from admission to PACU till first request for analgesia
Time frame: 48 hours postoperative
the amount of analgesic drugs in mg given in the first 48h postoperative
Time frame: 180 minutes postoperative
Time frame: 180 minutes postoperative.
Time frame: 60 minutes postoperative
Time frame: 48 hours postoperative
the score will be recorded once at the end of the study
Time frame: Intra-operative
Time frame: Intra-operative
Time frame: 48 hours postoperative
the pain score will be assessed at frequent intervals in the 1st 48 h postoperative
Assiut University
Other
Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
Acronym: TKversusCK
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