Clinical Trial: Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Pilot Study Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Brief Summary: Circumcision is the most common surgical procedure performed by Pediatric Urologists. Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic regimens without the commonly associated adverse effects. This study aims to see if giving ketorolac during the operation will result in better pain control. We hypothesize that ketorolac will result in pain control similar to morphine with a lower incidence of side effects such as nausea and vomiting.

Detailed Summary:

Prospective, randomized, single-blinded study will be conducted from January 2017- December 2017. A total of two groups will present. Patients with planned circumcision surgery will initially be identified by the surgeon. Patients will then be randomized into treatment (perioperative ketorolac) or control groups (no ketorolac).

A computer-generated randomized block design program will be used to allocate patients to either the treatment (ketorolac) or control (no ketorolac) group. All children will receive a 15 mg/kg oral dose of acetaminophen prior to surgery unless contraindicated. General anesthesia will be induced with sevoflurane via facemask. After establishing venous access, a laryngeal mask will be inserted, and anesthesia maintained with 1 minimum alveolar anesthetic concentration (MAC) of sevoflurane in oxygen/air 50/50 mixture. The DPNB nerve block will be performed by a pediatric urologist using a 23 GA needle inserted below the Buck fascia. Once the needle tip is positioned appropriately, and after a negative aspiration test, 0.2mL/kg (maximum 10mL) of 0.25% bupivacaine is injected in small aliquots, with intermittent aspiration throughout. In all patients, skin incision is performed at least 5 min after placement of the nerve block. At the beginning of the circumcision procedure once the patient is asleep, patients in the treatment group will receive a 0.5 mg/kg intravenous dose of ketorolac. Patients will be advised to take ibuprofen and acetaminophen post-operatively as needed.

Patients' demographic information, time needed to perform the block, time of block onset and duration of surgery will be recorded. The mean arterial pressure, heart rate and oxygen saturation, expired sevoflurane end tidal concentration and MAC will be systematically collected pre-operatively, intra-operatively and post-operatively i
Sponsor: Alberta Children's Hospital

Current Primary Outcome:

  • Post-operative pain [ Time Frame: Immediately following the procedure ]
    Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Wong-Baker FACES scale ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the Wong-Baker FACES scale will be used in patients capable of self-assessment. Both scores are out of 10 and can be averaged together to quantify post-operative pain
  • Post-operative pain [ Time Frame: 15 minutes post-operatively ]
    Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Wong-Baker FACES scale ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the Wong-Baker FACES scale will be used in patients capable of self-assessment. Both scores are out of 10 and can be averaged together to quantify post-operative pain
  • Post-operative pain [ Time Frame: 30 minutes post-operatively ]
    Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Wong-Baker FACES scale ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the Wong-Baker FACES scale will be used in patients capable of self-assessment. Both scores are out of 10 and can be averaged toge

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Total ibuprofen consumption [ Time Frame: 24 hours post-operatively ]
      Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
    • Total acetaminophen consumption [ Time Frame: 24 hours post-operatively ]
      Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
    • Incidence of bleeding requiring medical attention [ Time Frame: Up to 2 weeks ]
      Bleeding events will be compiled through post-anesthetic care unit, surgical short stay unit, clinic and emergency department notes


    Original Secondary Outcome: Same as current

    Information By: Alberta Children's Hospital

    Dates:
    Date Received: November 18, 2016
    Date Started: February 2017
    Date Completion: December 2017
    Last Updated: November 22, 2016
    Last Verified: November 2016