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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
Assiut university hospitals
Asyut, Assiut Governorate, Egypt
time to first request for postoperative analgesia
time in hours from admission to PACU till first request for analgesia
Time frame: 48 hours postoperative
total consumption of postoperative analgesics
the amount of analgesic drugs in mg given in the first 48h postoperative
Time frame: 48 hours postoperative
The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
Time frame: 180 minutes postoperative
Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
Time frame: 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).
Time frame: 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
Time frame: 48 hours postoperative
noninvasive blood pressure
Time frame: Intra-operative
heart rate
Time frame: Intra-operative
Verbal Numeric Rating Scale (VNRS)
the pain score will be assessed at frequent intervals in the 1st 48 h postoperative
Time frame: 48 hours postoperative
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0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure