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NCT Number: NCT07305883

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal Ketorolac Tromethamine

Drug

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 ketamine

Drug

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 outcomes

  1. Block pain intensity

    Time frame: Immediately after block

    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.

Secondary outcomes

  1. Nasal irritation

    Time frame: 60 minutes after the block

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

  2. Side effects

    Time frame: From the drug administration to 60 minutes after the block

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

  3. Patient satisfaction score

    Time frame: 60 minutes after the drug administration.

    The patients will be asked about their satisfaction using a 3-level Likert like scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Hadi Mirfazaelian, MD

CONTACT

[email protected]

00982161192240

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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