Ketorolac for Moderate to Severe Abdominal Pain in Children

NCT04528563 | Completed Phase 3 DMC

• 1 other identifier: 582125
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

In children and adolescents (older than 6 years in age) who arrive in the pediatric emergency department because they have been having 5 days or less of abdominal pain (possible appendicitis), will patients who are treated with ketorolac get just as much pain relief as those patients treated with morphine? To answer this research question, we will need a large number of patients in a study. To ensure we have enough patients, we must include many hospitals in different cities and provinces in the same study. Before doing this, though, we must first test a smaller version of the study in our center at McMaster Children's hosptial. The goal of doing this at McMaster first is to make sure or understand:

1. 1.We can enroll enough people in our study over 1 year
2. 2.We can make sure that all the information we collect from patients is complete and nothing is missing
3. 3.Reasons behind why people don't want to participate in the study
4. 4.How satisfied patients and their caregivers were with the study

Conditions

Abdominal Pain; Appendicitis; Analgesia; Child, Only; Emergencies

Outcome Measures

Primary Outcomes (3)

• Feasibility Outcomes

  proportion of patients consented from total eligible patients approached

  2 hours

• Feasibility Outcomes

  Proportion of participants who completed outcome assessment at all time points

  2 hours

• Feasibility Outcomes

  Proportion of missing items on individual data collection forms (screening forms, baseline characteristics, outcome assessment, follow up survey)

  14 days

Secondary Outcomes (4)

• Study Satisfaction

  14 days

• Declining consent

  2 hours

• withdrawing consent

  2 hours

• full study completion

  14 days

Other Outcomes (7)

• Clinical Outcomes

  2 hours

• Clinical Outcomes

  2 hours

• Clinical Outcomes

  2 hours

Study Arms (2)

Ketorolac Tromethamine

EXPERIMENTAL

IV ketorolac tromethamine, 0.5 mg/kg to a maximum of 30 mg plus IV morphine placebo;

Drug: Ketorolac Tromethamine 10 MG/ML

Morphine Sulfate

ACTIVE COMPARATOR

IV morphine 0.1 mg/kg to a maximum of 5 mg plus IV ketorolac placebo

Drug: Morphine Sulfate 10Mg/1mL Injection

Interventions

Ketorolac Tromethamine 10 MG/ML DRUG

Non-Steroidal-Anti-Inflammatory given intravenously.

Ketorolac Tromethamine

Morphine Sulfate 10Mg/1mL Injection DRUG

Opioid commonly used for acute abdominal pain given intravenously.

Morphine Sulfate

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6.0 years to \<18 years: Children aged \< 6 years of age at low risk for appendicitis and often present atypically.46,47
• Duration of abdominal pain ≤ 5 days: Children with longer durations of acute abdominal pain are less likely to have appendicitis.18,48
• A clinical decision to investigate for appendicitis as a possible etiology by the ED MD or RN. The physician or bedside nurse are suspicious of a diagnosis of appendicitis as a cause for the abdominal pain as reflected by the initiation of the appendicitis medical directive (an advanced nursing directive that allows nurses to order tests for patients with suspected appendicitis) and order laboratory tests and/or advanced imaging or directly consult pediatric surgery to rule out appendicitis.
• Patient has an IV cannula in situ or ordered to be placed: we will not include patients without an IV ordered or established in order to ensure the study intervention is limited to the study drugs and is not associated with the performance of any invasive procedures.
• Currently experiencing moderate to severe pain: self-reported pain score ≥5 using the VNRS at the time of enrollment.

You may not qualify if:

• Previous enrollment in trial (to ensure all observations are independent and not paired)
• NSAID use within 3 hours and/or opioid use within 2 hours prior to recruitment to avoid over-dosing and confounding
• Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions
• Chronic pain requiring daily analgesic use for other indications (e.g. naproxen for juvenile idiopathic arthritis): confounding
• History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations: Bleeding risk
• History of chronic and active renal disease, excluding renal calculi and urinary tract infections
• History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology), as ketorolac is metabolized in the liver.
• Known pregnancy at the time of enrollment, a positive pregnancy test in females ≥ 12 years in age or breastfeeding females due to the risk of premature closure of patent ductus arteriosus
• Known hypersensitivity to NSAIDs or opioids (e.g. naproxen, ibuprofen, acetylsalicylic acid, ketoprofen or ketorolac, morphine, hydromorphone, fentanyl)
• Absence of a parent/guardian for children who are \< 16 years in age: youths who are ≥16 years can provide us with informed consent without the permission of a guardian
• Inability to obtain consent due to a significant language barrier, in the absence of a native language translator

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L9H6k6, Canada

Location

Related Publications (1)

• Eltorki M, Busse JW, Freedman SB, Thompson G, Beattie K, Serbanescu C, Carciumaru R, Thabane L, Ali S. Intravenous ketorolac versus morphine in children presenting with suspected appendicitis: a pilot single-centre non-inferiority randomised controlled trial. BMJ Open. 2022 Apr 5;12(4):e056499. doi: 10.1136/bmjopen-2021-056499.

  PMID: 35383071 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Appendicitis; Agnosia; Emergencies

Interventions

Ketorolac Tromethamine; Morphine; Injections

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mohamed Eltorki, MBChB

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: double dummy design

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 27, 2020
• Study Start: May 5, 2021
• Primary Completion: February 5, 2023
• Study Completion: February 6, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when the database has been locked and data has been unblinded.
• Access Criteria: The data that support the findings of this study are available from the corresponding author (M.E), upon reasonable request

Locations

CA (1)