Clinical trial NCT02462174: Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
Official title: Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: anesthesia
analgesia
caudal
ketamine
bupivacaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 80
Sex: MALE
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. age (6 months to 6 years)
2. ASA physical status I or II.
3. Operation: elective unilateral inguinal herniotomy.

Exclusion Criteria:

1. A history of developmental delay or mental retardation,
2. Known or suspected coagulopathy,
3. Known allergy to any local anaesthetic,
4. Known congenital anomaly of the spine or signs of spinal anomaly,
5. Infection at the sacral region.

Primary outcomes:
measure: time to first request for postoperative analgesia
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: total consumption of postoperative analgesics
timeFrame: 48 hours postoperative
measure: The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
timeFrame: 180 minutes postoperative
measure: Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
timeFrame: 180 minutes postoperative.
measure: 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).
timeFrame: 60 minutes postoperative
measure: parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
timeFrame: 48 hours postoperative
measure: noninvasive blood pressure
timeFrame: Intra-operative
measure: heart rate
timeFrame: Intra-operative
measure: Verbal Numeric Rating Scale (VNRS)
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut governorate
Study officials:
affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: