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Completed

NCT Number: NCT02462174

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

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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Key information

Age range

6 month–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age (6 months to 6 years)
  • ASA physical status I or II.
  • Operation: elective unilateral inguinal herniotomy.

Exclusion criteria

  • A history of developmental delay or mental retardation,
  • Known or suspected coagulopathy,
  • Known allergy to any local anaesthetic,
  • Known congenital anomaly of the spine or signs of spinal anomaly,
  • Infection at the sacral region.

Treatment and study plan

ketamine

Drug

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

Other names: Katalar

Bupivacaine

Drug

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

Other names: bucaine

Primary outcomes

  1. time to first request for postoperative analgesia

    Time frame: 48 hours postoperative

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

Secondary outcomes

  1. total consumption of postoperative analgesics

    Time frame: 48 hours postoperative

    the amount of analgesic drugs in mg given in the first 48h postoperative

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

    Time frame: 180 minutes postoperative

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

    Time frame: 180 minutes postoperative.

  4. 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).

    Time frame: 60 minutes postoperative

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

    Time frame: 48 hours postoperative

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

  6. noninvasive blood pressure

    Time frame: Intra-operative

  7. heart rate

    Time frame: Intra-operative

  8. Verbal Numeric Rating Scale (VNRS)

    Time frame: 48 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: TKversusCK

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2015
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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