Clinical TrialKetaminePlaceboNot yet recruiting

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

This Phase III, randomised, quadruple-masked, parallel trial (n=64) will assess the analgesic effectiveness and side-effect profile of intranasal ketorolac versus intranasal ketamine in adults presenting to the emergency department with finger injuries who require a digital nerve block, with primary outcome block pain intensity measured immediately after the block using the Numeric Rating Scale (NRS). Participants will be randomised to receive either 30 mg intranasal ketorolac tromethamine or 50 mg intranasal ketamine, each administered via mucosal atomizer with half the dose (0.5 cc) in each nostril 5 minutes before the digital nerve block. Secondary endpoints include nasal irritation, other adverse effects and patient satisfaction. Key eligibility criteria include age 18–65 years, weight >50 kg, requirement for digital nerve block and ability to provide informed consent; notable exclusions include pregnancy or breastfeeding, hypersensitivity to NSAIDs, recent analgesic use within 6 hours, significant renal or hepatic failure, nasal congestion or upper respiratory infection and coagulation disorders. The study is sponsored by Tehran University of Medical Sciences and is planned to start on 28 December 2025 with expected completion on 1 August 2026.

Target Enrollment
64 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

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 Arms & Interventions

Intranasal Ketamine

active comparator

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

Interventions

  • Ketamine

Intranasal Ketorolac Tromethamine

experimental

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.

Interventions

  • Placebo

    Unmatched intervention: Intranasal Ketorolac Tromethamine

Participants

Ages
1865
Sexes
Male & Female

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 Details

  • Status
    Not yet recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment64 participants
  • Timeline
    Start: 2025-12-28
    End: 2026-08-01
  • Compounds

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