Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain

Intranasal Ketorolac Effectiveness In Comparison To Intranasal Ketamine for Digital Nerve Block Pain; A Randomized, Double Blind Trial

This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac versus intranasal ketamine for reducing pain prior to digital nerve block procedures in patients with finger injuries in emergency department.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Digital Block
• Intervention / Treatment: Drug: Intranasal ketamine; Drug: Intranasal Ketorolac Tromethamine

Detailed Description

Acute pain management in emergency department during painful procedures such as digital nerve block is crucial to be implemented in a rapid-onset method. Ketorolac, a potent NSAID, and ketamine, an NMDA receptor antagonist with analgesic effects, have both been shown to be effective and fast-onset when administered intranasally. This non-invasive method of Ketorolac is not supported by sufficient evidences in such clinical scenarios. Addressing this research gap may lead to reduced pain and complications, as well as higher patient satisfaction, contributing the development of novel pre-procedural analgesic strategies in emergency settings.

Participants will be randomly assigned to receive either 30 mg intranasal ketorolac or 50 mg intranasal ketamine, administered 5 minutes prior to the digital nerve block. Pain will be assessed using the Numeric Rating Scale (NRS). Secondary endpoints include nasal irritation, side effects, and patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hadi Mirfazaelian, MD; Phone Number: 00982161192240; Email: h-mirfazaelian@sina.tums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18-65 years
• Weight > 50 kg
• Requires digital nerve block
• Able to provide informed consent

Exclusion Criteria:

• Active peptic ulcer disease (PUD)
• History of hypersensitivity to NSAIDs
• Pregnancy and breastfeeding
• Renal failure
• Hepatic failure
• Patients who have received analgesics within the past 6 hours
• Nasal congestion
• Upper respiratory tract infection
• Patients with a history of kidney transplantation
• Active gastrointestinal bleeding
• Systolic blood pressure less than 90 mmHg or greater than 180 mmHg
• Heart rate less than 50 per minute or greater than 150 per minute
• Concurrent use of NSAIDs or anticoagulant drugs
• Inability to provide informed consent
• Anatomical abnormalities of the nose or skull base (congenital or acquired)
• Hyperreactive airway disease such as severe asthma
• Coagulation disorders
• Intracranial hemorrhage
• Suspected aortic dissection
• Suspected rupture of abdominal aortic aneurysm
• History of gastrointestinal perforation
• Gastrointestinal bleeding within the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intranasal Ketamine; 50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block	Drug: Intranasal ketamine; 50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block
Experimental: Intranasal Ketorolac Tromethamine; 30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block.	Drug: Intranasal Ketorolac Tromethamine; 30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block pain intensity	The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.	Immediately after block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal irritation	We will ask the patients about this outcome use a 3-level Likert-like scale.	60 minutes after the block
Side effects	The patients will be assessed every 15 minutes for this outcome.	From the drug administration to 60 minutes after the block
Patient satisfaction score	The patients will be asked about their satisfaction using a 3-level Likert like scale.	60 minutes after the drug administration.

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Hadi Mirfazaelian, Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 1404-5-243-91681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The information is not allowed to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No