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Not yet recruiting NCT07305883

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

Phase III Interventional Pain Digital Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intranasal Ketorolac Tromethamine, Intranasal ketamine.
Who it may be relevant to
Registry conditions: Pain, Digital Block. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

  • 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.
  • 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

Primary outcome measures

  • Block pain intensity [Time frame: Immediately after block]
Secondary outcome measures (3)
  • Nasal irritation [Time frame: 60 minutes after the block]
  • Side effects [Time frame: From the drug administration to 60 minutes after the block]
  • Patient satisfaction score [Time frame: 60 minutes after the drug administration.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07305883 · 1404-5-243-91681

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗