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

Phase 3Not Yet RecruitingNCT07305883

Tehran University of Medical Sciences64 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain Digital Block

Interventions

Intranasal Ketorolac TromethamineDRUG

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.

Intranasal ketamineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Immediately after block

Secondary Outcomes

Nasal irritation

We will ask the patients about this outcome use a 3-level Likert-like scale.

Time frame: 60 minutes after the block

Side effects

The patients will be assessed every 15 minutes for this outcome.

Time frame: 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.

Time frame: 60 minutes after the drug administration.

Central Contacts

Hadi Mirfazaelian, MD

CONTACT

00982161192240 h-mirfazaelian@sina.tums.ac.ir

Data from ClinicalTrials.gov

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