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

Tehran University of Medical Sciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Digital Block; Pain

Treatments: Drug: Intranasal Ketorolac Tromethamine; Drug: Intranasal ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07305883

1404-5-243-91681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Intranasal Ketamine

Active Comparator group

Description:

50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block

Treatment:

Drug: Intranasal ketamine

Intranasal Ketorolac Tromethamine

Experimental group

Description:

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.

Treatment:

Drug: Intranasal Ketorolac Tromethamine