Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

NCT02973958 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: REB16-1876
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Phimosis; Paraphimosis; Balanitis

Keywords

Penis; Pain; Ketorolac; Circumcision

Outcome Measures

Primary Outcomes (10)

• Post-operative pain

  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

  Immediately following the procedure

• Post-operative pain

  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

  15 minutes post-operatively

• Post-operative pain

  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

  30 minutes post-operatively

• Post-operative pain

  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

  45 minutes post-operatively

• Post-operative pain

  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

  60 minutes post-operatively

• Post-operative pain

  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

  90 minutes post-operatively

• Post-operative pain

  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

  120 minutes post-operatively

• Post-operative pain

  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

  150 minutes post-operatively

• Post-operative pain

  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

  180 minutes post-operatively

• Post-operative pain

  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

  24 hours post-operatively

Secondary Outcomes (3)

• Total ibuprofen consumption

  24 hours post-operatively

• Total acetaminophen consumption

  24 hours post-operatively

• Incidence of bleeding requiring medical attention

  Up to 2 weeks

Study Arms (2)

No ketorolac

ACTIVE COMPARATOR

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; Drug: Sevoflurane; Drug: Acetaminophen; Drug: Ibuprofen

Peri-operative ketorolac

EXPERIMENTAL

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; Drug: Sevoflurane; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Ketorolac

Interventions

Bupivacaine DRUG

See active comparator description

Also known as: Marcaine

No ketorolac; Peri-operative ketorolac

Sevoflurane DRUG

See active comparator description

Also known as: Sevorane, Ultane, Sojourn

No ketorolac; Peri-operative ketorolac

Acetaminophen DRUG

See active comparator description

Also known as: Tylenol

No ketorolac; Peri-operative ketorolac

Ibuprofen DRUG

See active comparator description

Also known as: Advil

No ketorolac; Peri-operative ketorolac

Ketorolac DRUG

See experimental arm description

Also known as: Toradol

Peri-operative ketorolac

Eligibility Criteria

• Age: Up to 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alberta Children's Hospital: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (12)

• 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.

  PMID: 12804449 BACKGROUND

• 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.

  PMID: 15495086 BACKGROUND

• 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.

  PMID: 22227789 BACKGROUND

• 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.

  PMID: 11158494 BACKGROUND

• 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.

  PMID: 7644238 BACKGROUND

• 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.

  PMID: 7486094 BACKGROUND

• 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.

  PMID: 21965355 BACKGROUND

• 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.

  PMID: 16996689 BACKGROUND

• 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.

  PMID: 9220806 BACKGROUND

• 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.

  PMID: 15818080 BACKGROUND

• 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.

  PMID: 14527704 BACKGROUND

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

  BACKGROUND

Related Links

• Ketorolac compound summary. Pubchem Substance Website. National Center for Biotechnology, US National Library of Medicine

MeSH Terms

Conditions

Pain, Postoperative; Phimosis; Paraphimosis; Balanitis; Pain

Interventions

Bupivacaine; Sevoflurane; Acetaminophen; Ibuprofen; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Acetanilides; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bryce Weber, MD FRCSC

  Alberta Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Urologist

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 28, 2016
• Study Start: February 1, 2017
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

CA (1)