Digital Block, Pain
Conditions
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.
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
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.
DRUGIntranasal 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
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Block pain intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Nasal irritation | 60 minutes after the block | We will ask the patients about this outcome use a 3-level Likert-like scale. |
| Side effects | From the drug administration to 60 minutes after the block | The patients will be assessed every 15 minutes for this outcome. |
| Patient satisfaction score | 60 minutes after the drug administration. | The patients will be asked about their satisfaction using a 3-level Likert like scale. |
Contacts
Primary ContactHadi Mirfazaelian, MD
Outcome results
None listed