Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision - Full Text View

Purpose

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	Intervention	Phase
Pain, Postoperative Phimosis Paraphimosis Balanitis	Drug: Bupivacaine Drug: Sevoflurane Drug: Acetaminophen Drug: Ibuprofen Drug: Ketorolac	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Supportive Care
Official Title:	A Pilot Study Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Resource links provided by NLM:

Drug Information available for: Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Further study details as provided by Bryce Weber, Alberta Children's Hospital:

Primary Outcome Measures:

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 together to quantify post-operative pain
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
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
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
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
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
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
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:

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


Estimated Enrollment:	30
Actual Study Start Date:	February 1, 2017
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	February 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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