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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Ketamine; Drug: Bupivacaine; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut governorate
    • Assiut, Assiut governorate, Egypt, 715715
      • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (ESTIMATE): June 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: anesthesia; ketamine; analgesia; bupivacaine; caudal
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anesthetics, Local; Ketamine; Bupivacaine
• Other Study ID Numbers: IRB00008718/ NF