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

NCT07305883 | Not Yet Recruiting Phase 3

• 1 other identifier: 1404-5-243-91681
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Digital Block; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after block

Secondary Outcomes (3)

• Nasal irritation

  60 minutes after the block

• Side effects

  From the drug administration to 60 minutes after the block

• Patient satisfaction score

  60 minutes after the drug administration.

Study Arms (2)

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

Drug: Intranasal 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.

Drug: Intranasal Ketorolac Tromethamine

Interventions

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 Ketorolac Tromethamine

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

Intranasal Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• Weight \> 50 kg
• Requires digital nerve block
• Able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hadi Mirfazaelian

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadi Mirfazaelian, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 26, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share