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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.

Bupivacaine

Intervention Type DRUG

1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route

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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.

Bupivacaine

Intervention Type DRUG

0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure

Interventions

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Ketamine

0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.

Intervention Type DRUG

Ketamine

0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.

Intervention Type DRUG

Bupivacaine

1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route

Intervention Type DRUG

Bupivacaine

0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure

Intervention Type DRUG

Other Intervention Names

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Katalar Katalar bucaine bucaine

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No