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Ketorolac for Phimosis

Phase 2

Recruiting

Led By Bryce Weber, MD FRCSC

Research Sponsored by Alberta Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-operatively

Awards & highlights

Study Summary

This trial is testing whether ketorolac is an effective painkiller for circumcision with fewer side effects than morphine.

Eligible Conditions

Phimosis
Balanitis
Paraphimosis
Postoperative Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Secondary outcome measures

Incidence of bleeding requiring medical attention

Total acetaminophen consumption

Total ibuprofen consumption

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peri-operative ketorolacExperimental Treatment5 Interventions

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.

Group II: No ketorolacActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacain

2022

Completed Phase 4

~1610

Sevoflurane

2016

Completed Phase 4

~1260

Acetaminophen

2017

Completed Phase 4

~2030

Ibuprofen

2013

Completed Phase 4

~5800

Ketorolac

2014

Completed Phase 4

~1760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alberta Children's HospitalLead Sponsor

53 Previous Clinical Trials

39,927 Total Patients Enrolled

1 Trials studying Phimosis

30 Patients Enrolled for Phimosis

Bryce Weber, MD FRCSCPrincipal InvestigatorAlberta Children's Hospital

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Phimosis

30 Patients Enrolled for Phimosis

Media Library

Ketorolac Clinical Trial Eligibility Overview. Trial Name: NCT04646967 — Phase 2

Phimosis Research Study Groups: Peri-operative ketorolac, No ketorolac

Phimosis Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT04646967 — Phase 2

Ketorolac 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646967 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Ketorolac for use in medical treatments?

"Ketorolac earned a safety score of 2 on our scale since Phase 2 trials have demonstrated satisfactory levels of security, although efficacy has yet to be proven."

Answered by AI

Are there still slots available for participation in this experiment?

"Clinicaltrials.gov informs that this study is not in search of participants, despite being posted on August 20th 2022 and recently edited on the 14th of the same month. Nonetheless, there are still 750 clinical trials currently searching for individuals to take part."

Answered by AI

How is Ketorolac generally prescribed to alleviate symptoms?

"Ketorolac is a viable treatment for pemphigus, as well as other conditions such uveitis, catarrh and lupus erythematosus."

Answered by AI

What prior experiments have been conducted concerning the efficacy of Ketorolac?

"Presently, there are 268 studies assessing the efficacy of ketorolac. 60 of these have progressed to Phase 3 testing, with a majority conducted in Boston, MA and 1355 sites across the country offering similar research opportunities."

Answered by AI

How many volunteers have signed up for the study thus far?

"Unfortunately, the trial has already closed its recruitment. It was initially posted on August 20th 2022 and edited a week later. However, if you are still interested in taking part in clinical trials related to balanitis, there are currently 482 studies actively looking for participants; alternatively, 268 trials for Ketorolac have started recruiting as well."

Answered by AI

Recent research and studies

PainJournal

Analgesic Efficacy and Safety of Single-dose Intramuscular Ketorolac for Postoperative Pain Management in Children Following Tonsillectomy

Sutters, Kimberly A., Jon D. Levine, Suzanne Dibble, Marilyn Savedra, and Christine Miaskowski. 1995. “Analgesic Efficacy and Safety of Single-dose Intramuscular Ketorolac for Postoperative Pain Management in Children Following Tonsillectomy”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0304-3959(94)00166-c.

Anesthesia & AnalgesiaJournal

Perioperative Single Dose Ketorolac to Prevent Postoperative Pain

De Oliveira, Gildasio S., Deepti Agarwal, and Honorio T. Benzon. 2012. “Perioperative Single Dose Ketorolac to Prevent Postoperative Pain”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3182334d68.

PainJournal

Systematic Review of Observational (behavioral) Measures of Pain for Children and Adolescents Aged 3 to 18 Years

von Baeyer, Carl L., and Lara J. Spagrud. 2007. “Systematic Review of Observational (behavioral) Measures of Pain for Children and Adolescents Aged 3 to 18 Years”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.pain.2006.08.014.

Nursing in Critical CareJournal