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

Condition(s) targeted: Postoperative Pain

Intervention: Ketamine (Drug); Ketamine (Drug); Bupivacaine (Drug); Bupivacaine (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Assiut University

Official(s) and/or principal investigator(s):
Hala S Abdel-Ghaffar, MD, Principal Investigator, Affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

Overall contact:
Hala S Abdel-Ghaffar, MD, Phone: +2 01003812011, Email: hallasaad@yahoo.com

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: time to first request for postoperative analgesia

Secondary outcome:

total consumption of postoperative analgesics

The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score

Faces Legs Activity Cry Consolability tool (FLACC, 0-10).

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).

parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).

noninvasive blood pressure

heart rate

Verbal Numeric Rating Scale (VNRS)

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.

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Male.

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.

Hala S Abdel-Ghaffar, MD, Phone: +2 01003812011, Email: hallasaad@yahoo.com

Assiut university hospitals, Assiut, Assiut governorate 715715, Egypt; Recruiting
Hala S Abdel-Ghaffar, MD, Phone: +2 01003812011, Email: hallasaad@yahoo.com
Seham M Moeen, MD, Phone: +2 01006386324, Email: seham.moeen@yahoo.com

Starting date: May 2015
Last updated: July 15, 2015