- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646967
An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
A Randomized Control Trial Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We performed a pilot study in 2017 evaluating the perioperative use of ketorolac in circumcision. Overall, there were no adverse reactions and ketorolac patients did not experience significantly less pain that the control group patients. However, parental perception of pain was lower in the ketorolac group when compared to the control and this required more investigation. Based on our findings of the pilot study, we determined that we needed at least 36 patients in each study group to come to a statistical conclusion. With a larger study group perhaps a statistical difference in pain as measured with a FLACC score may become apparent.
Prospective, randomized, single-blinded study will be conducted from January 2021 - January 2022. A total of two groups will present with 50 children in each group.
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, but not ibuprofen within 6 hours of the procedure. A 6-hour window between ibuprofen and ketorolac is in line with our standard of practice at the Alberta Children's Hospital when using additional NSAIDs after ketorolac.
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 in the recovery room. The primary outcome of post-operative pain will be evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The usage of these two scales will be performed as deemed appropriate by the research assistant. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment (> 7 years of age). The FLACC score is a well-established postoperative pain measure using 5 items scored between 0-2, which has been validated in patients from 6 months up to 7 years of age. These faces are rated on a scale of 10. A FLACC or NRS pain score will be recorded every 15 minutes for the first hour and every 30 minutes for up to 2 hours following discharge from the PACU into the day stay surgical unit. If the score is found to be >3 (moderate pain 4-6, severe pain 7-10), the patient will receive an intravenous morphine dose of 0.05mg/kg. An additional dose may be given 15 minutes following the initial dose of morphine if analgesia is inadequate (score >4). Postoperatively, the child will be monitored every 15 minutes during the first hour and every 30 minutes for the next 2 hours until discharge home. Discharge will be based on normal institutional criteria including level of awareness, hemodynamic stability and absence of pain, bleeding, nausea and vomiting. Prior to discharge, parents will be provided with any additional analgesics required at home and will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity, which has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone at a time corresponding to 24 hours post-surgical closure. Amount of pain and analgesia consumption data will then be collected by contacting the parents 24 hours post procedure.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bryce Weber, MD FRCSC
- Phone Number: 5872276652
- Email: bryce.weber@albertahealthservices.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Recruiting
- Alberta Children's Hospital
-
Contact:
- Bryce Weber, MD FRCSC
- Phone Number: 587-227-6652
- Email: bryce.weber@albertahealthservices.ca
-
Principal Investigator:
- Bryce Weber, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 postoperatively as needed.
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See active comparator description
Other Names:
See active comparator description
Other Names:
See active comparator description
Other Names:
See active comparator description
Other Names:
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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.
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See active comparator description
Other Names:
See active comparator description
Other Names:
See active comparator description
Other Names:
See active comparator description
Other Names:
See experimental arm description
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain
Time Frame: Immediately following the procedure
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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Immediately following the procedure
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Post-operative pain
Time Frame: 15 minutes post-operatively
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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
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15 minutes post-operatively
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Post-operative pain
Time Frame: 30 minutes post-operatively
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Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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30 minutes post-operatively
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Post-operative pain
Time Frame: 45 minutes post-operatively
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Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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45 minutes post-operatively
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Post-operative pain
Time Frame: 60 minutes post-operatively
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Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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60 minutes post-operatively
|
Post-operative pain
Time Frame: 90 minutes post-operatively
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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90 minutes post-operatively
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Post-operative pain
Time Frame: 120 minutes post-operatively
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
|
120 minutes post-operatively
|
Post-operative pain
Time Frame: 150 minutes post-operatively
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
|
150 minutes post-operatively
|
Post-operative pain
Time Frame: 180 minutes post-operatively
|
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score 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 NRS pain score will be used in patients capable of self-assessment.
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180 minutes post-operatively
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Post-operative pain
Time Frame: 24 hours post-operatively
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Evaluated through use of Parents' Post-operative Pain Measure (PPPM) completed via telephone follow-up with parent/guardian 24-hours post-operative.
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24 hours post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total ibuprofen consumption
Time Frame: 24 hours post-operatively
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Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
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24 hours post-operatively
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Total acetaminophen consumption
Time Frame: 24 hours post-operatively
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Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
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24 hours post-operatively
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Incidence of bleeding requiring medical attention
Time Frame: Up to 2 weeks
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Bleeding events will be compiled through post-anesthetic care unit, surgical short stay unit, clinic and emergency department notes
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Up to 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bryce Weber, MD FRCSC, Alberta Children's Hospital
Publications and helpful links
General Publications
- American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004217. doi: 10.1002/14651858.CD004217.pub2.
- von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.
- Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
- De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
- Allan CY, Jacqueline PA, Shubhda JH. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2003;(2):CD003005. doi: 10.1002/14651858.CD003005.
- Adler R, Ottaway MS, Gould S. Circumcision: we have heard from the experts; now let's hear from the parents. Pediatrics. 2001 Feb;107(2):E20. doi: 10.1542/peds.107.2.e20.
- Sutters KA, Levine JD, Dibble S, Savedra M, Miaskowski C. Analgesic efficacy and safety of single-dose intramuscular ketorolac for postoperative pain management in children following tonsillectomy. Pain. 1995 Apr;61(1):145-153. doi: 10.1016/0304-3959(94)00166-C.
- Gunter JB, Varughese AM, Harrington JF, Wittkugel EP, Patankar SS, Matar MM, Lowe EE, Myer CM 3rd, Willging JP. Recovery and complications after tonsillectomy in children: a comparison of ketorolac and morphine. Anesth Analg. 1995 Dec;81(6):1136-41. doi: 10.1097/00000539-199512000-00004.
- Chambers CT, Hardial J, Craig KD, Court C, Montgomery C. Faces scales for the measurement of postoperative pain intensity in children following minor surgery. Clin J Pain. 2005 May-Jun;21(3):277-85. doi: 10.1097/00002508-200505000-00011.
- Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 4.4: 287-291, 2005
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Penile Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Pain, Postoperative
- Balanitis
- Phimosis
- Paraphimosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Anesthetics, Local
- Anesthetics, Inhalation
- Ketorolac
- Acetaminophen
- Sevoflurane
- Bupivacaine
- Ibuprofen
Other Study ID Numbers
- REB20-1076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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