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

NCT ID: NCT07305883

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-28

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Pain Digital Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Intranasal ketamine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intranasal Ketorolac Tromethamine

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hadi Mirfazaelian

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Central Contacts

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Hadi Mirfazaelian, MD

Role: CONTACT

Phone: 00982161192240

Email: [email protected]

Other Identifiers

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1404-5-243-91681

Identifier Type: -

Identifier Source: org_study_id