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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Ketamine; Drug: Bupivacaine

• Registration Number: NCT02462174
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical ketamine and topical bupivacaine	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.
Topical ketamine and topical bupivacaine	Ketamine	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.
Caudal ketamine and caudal bupivacaine	Ketamine	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.
Caudal ketamine and caudal bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
time to first request for postoperative analgesia	48 hours postoperative	time in hours from admission to PACU till first request for analgesia

Secondary Outcome Measures

Name	Time	Method
noninvasive blood pressure	Intra-operative
total consumption of postoperative analgesics	48 hours postoperative	the amount of analgesic drugs in mg given in the first 48h 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).	48 hours postoperative	the score will be recorded once at the end of the study
heart rate	Intra-operative
Verbal Numeric Rating Scale (VNRS)	48 hours postoperative	the pain score will be assessed at frequent intervals in the 1st 48 h postoperative

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Assiut governorate, Egypt