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Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

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ClinicalTrials.gov Identifier: NCT02973958
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Bryce Weber, Alberta Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Phimosis Paraphimosis Balanitis Drug: Bupivacaine Drug: Sevoflurane Drug: Acetaminophen Drug: Ibuprofen Drug: Ketorolac Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Active Comparator: No ketorolac
15 mg/kg oral dose of acetaminophen is administered prior to surgery. 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 is done 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. Patients will be advised to take ibuprofen and acetaminophen post-operatively as needed.
Drug: Bupivacaine
See active comparator description
Other Name: Marcaine

Drug: Sevoflurane
See active comparator description
Other Names:
  • Sevorane
  • Ultane
  • Sojourn

Drug: Acetaminophen
See active comparator description
Other Name: Tylenol

Drug: Ibuprofen
See active comparator description
Other Name: Advil

Experimental: Peri-operative ketorolac
Exactly same as the no ketorolac group except at the beginning of the circumcision, once the patient is asleep, patients in the perioperative ketorolac group will also receive a 0.5 mg/kg intravenous dose of ketorolac.
Drug: Bupivacaine
See active comparator description
Other Name: Marcaine

Drug: Sevoflurane
See active comparator description
Other Names:
  • Sevorane
  • Ultane
  • Sojourn

Drug: Acetaminophen
See active comparator description
Other Name: Tylenol

Drug: Ibuprofen
See active comparator description
Other Name: Advil

Drug: Ketorolac
See experimental arm description
Other Name: Toradol




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 together to quantify post-operative pain

  4. Post-operative pain [ Time Frame: 45 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

  5. Post-operative pain [ Time Frame: 60 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

  6. Post-operative pain [ Time Frame: 90 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

  7. Post-operative pain [ Time Frame: 120 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

  8. Post-operative pain [ Time Frame: 150 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

  9. Post-operative pain [ Time Frame: 180 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

  10. Post-operative pain [ Time Frame: 24 hours 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 through telephone follow-up with parental input. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children admitted for circumcision at the Alberta Children's Hospital

Exclusion Criteria:

  • History of allergic reactions to local anesthetics or ketorolac
  • Bleeding diatheses
  • Coagulopathy
  • Infection at the injection site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973958


Contacts
Contact: Bryce Weber, MD FRCSC 5872276652 bryce.weber@albertahealthservices.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Bryce Weber, MD FRCSC    587-227-6652    bryce.weber@albertahealthservices.ca   
Principal Investigator: Bryce Weber, MD         
Sponsors and Collaborators
Alberta Children's Hospital
Investigators
Principal Investigator: Bryce Weber, MD FRCSC Alberta Children's Hospital

Additional Information:
Publications:
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 4.4: 287-291, 2005

Responsible Party: Bryce Weber, Pediatric Urologist, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT02973958     History of Changes
Other Study ID Numbers: REB16-1876
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bryce Weber, Alberta Children's Hospital:
Penis
Pain
Ketorolac
Circumcision

Additional relevant MeSH terms:
Penile Diseases
Pain, Postoperative
Phimosis
Balanitis
Paraphimosis
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Genital Diseases, Male
Bupivacaine
Sevoflurane
Acetaminophen
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents