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

Ketamine

Brief Summary

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

Intervention / Treatment

  • Ketamine (DRUG)
    0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
  • Bupivacaine (DRUG)
    0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 6 Months to 6 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 01, 2015
    Primary Completion: Sep 01, 2015 ACTUAL
    Completion Date: Sep 01, 2015 ACTUAL
    Study First Posted: Jun 03, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 01, 2015

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: Male
    Minimum Age: 1
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    • time in hours from admission to PACU till first request for analgesia

    Secondary Outcomes

    • 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

    • the score will be recorded once at the end of the study

    • noninvasive blood pressure Intra-operative
    • heart rate Intra-operative

    • the pain score will be assessed at frequent intervals in the 1st 48 h postoperative

    More Details

    NCT Number: NCT02462174
    Acronym: TKversusCK
    Other IDs: IRB00008718/ NF
    Study URL: https://clinicaltrials.gov/study/NCT02462174
    Last updated: Sep 29, 2023