Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.

NCT04441762 | Completed Phase 2

• 1 other identifier: InkArc2020
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Pain is a common reason for individuals to seek health care, especially emergency care. Ketorolac has numerous advantages over other pain medications, especially the opioids. The intranasal administration of ketorolac has been shown to be safe and effective in the treatment of postoperative pain following major abdominal surgery and post dental surgery, but there have been no studies evaluating the use of intranasal ketorolac for the treatment of acute renal colic pain in the emergency department. Methods: This is a double blinded randomized controlled trial. two hundred renal colic patients presented to the emergency department will be randomized to intervention (30 mg intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient, attending physician and administering nurse will be blinded throughout the study. The analgesic effects will be assessed by several measures including pain relief, pain intensity difference, global pain evaluation, global assessment of analgesia, and the summed pain intensity difference. The safety will be assessed by documentation of adverse events, vital signs, and clinical assessment before and after drug administration. Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to severe renal colic. Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS). Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge and recurrent visit within 24 hours. Patient Population: Adults (from age 18 to 64 years) who presents to emergency department (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Intervention: Single dose of intranasal ketorolac 30mg. Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented. Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given, tolerability and safety evaluation.

Conditions

Acute Renal Colic

Outcome Measures

Primary Outcomes (1)

• Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS)

  Change in visual analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).

  At 30 and 60 minutes

Secondary Outcomes (4)

• Adverse Events/Side Effects.

  48 hours

• The need of rescue pain medications.

  60 min During Emergency Visit

• Time to discharge.

  within 24 hours.

• Recurrent visit

  within 24 hours.

Study Arms (2)

intravenous

ACTIVE COMPARATOR

30 mg intravenous ketorolac in 10 ml syringe + 1 mL Normal Saline 9% using an intranasal device (0.5 ml in each nostril).

Drug: Intravenous Ketorolac Tromethamine

Intranasal

EXPERIMENTAL

30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml in each nostril) + 10 ml Intravenous Normal Saline 9%.

Drug: Intranasal Ketorolac Tromethamine

Interventions

Intravenous Ketorolac Tromethamine DRUG

30 mg ketorolac single dose

Also known as: ketorolac injection

intravenous

Intranasal Ketorolac Tromethamine DRUG

30 mg ketorolac single dose

Also known as: Atomized Intranasal Ketorolac

Intranasal

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with classical acute renal colic symptoms.
• Age ≥ 18 years and \< 65 years
• Stable patient with stable vital signs.
• Mentally competent patient who can understand and sign the consent form.
• Pain score is moderate to severe (visual analog scale 7 or more).

You may not qualify if:

• Patients who are allergic to ketorolac.
• Patients with active peptic ulcer disease.
• Patients with a history of asthma, urticaria, or other allergic-type reactions after taking NSAIDs.
• Patients with renal disease and renal transplant.
• Patients who are at risk for renal failure due to volume depletion.
• Pregnant or nursing mothers.
• Patients with any other contraindication to the use of ketorolac, or in whom the use of ketorolac would not be consistent with the approved package insert.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Aseeb, 123, Oman

Location

Related Publications (3)

• Arhami Dolatabadi A, Memary E, Kariman H, Nasiri Gigloo K, Baratloo A. Intranasal Desmopressin Compared with Intravenous Ketorolac for Pain Management of Patients with Renal Colic Referring to the Emergency Department: A Randomized Clinical Trial. Anesth Pain Med. 2017 Feb 25;7(2):e43595. doi: 10.5812/aapm.43595. eCollection 2017 Apr.

  PMID: 28824859 BACKGROUND

• Yazdani J, Khorshidi-Khiavi R, Nezafati S, Mortazavi A, Farhadi F, Nojan F, Ghanizadeh M. Comparison of analgesic effects of intravenous and intranasal ketorolac in patients with mandibular fracture-A Randomized Clinical Trial. J Clin Exp Dent. 2019 Sep 1;11(9):e768-e775. doi: 10.4317/jced.55753. eCollection 2019 Sep.

  PMID: 31636867 RESULT

• Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564.

  PMID: 20557145 RESULT

MeSH Terms

Conditions

Renal Colic

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Usama Al-Khalasi

  Oman Medical Speciality Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Resident

Model Details: case-control trial

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: December 30, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)