Intranasal Drug Administration, Ketorolac, Pain
Conditions
Keywords
Emergency department, pain, intranasal, ceiling effect, Ketorolac
Brief summary
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.
Detailed description
Pain control is one of the problems in emergency departments (EDs). Analgesics in the intranasal (IN) form have been come into interest and focus because of their ease of application and effectiveness. Recently, IN ketorolac at 30mg has been turned out to have comparable efficacy with parenteral forms. Considering the ceiling effect of the ketorolac, this trial will study whether lower dose of 20mg for pain management is equally effective as 30mg dose. The study is a multicenter, prospective, randomized, double blind, parallel group non inferiority clinical trial conducted in three EDs. Eligible participants are adults aged 18-65 years presenting with acute moderate to severe pain \[numeric rating scale (NRS)≥4\]. Participants will be randomized to receive atomized IN ketorolac 20 mg or 30 mg. Primary outcome is change in pain reduction at 30 minutes post administration. Secondary outcomes include pain reduction at 15, 45, and 60 minutes, requirement for rescue analgesia (IV morphine 0.1 mg/kg available at 30), gastrointestinal and other adverse effects, and patient satisfaction.
Interventions
DRUG20mg intranasal ketorolac
20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
DRUG30mg Intranasal Ketorolac
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
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 * Able to provide informed consent * Acute pain (\<48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)
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 * Chronic pain disorders * Substance misuse * Immediate opioid necessity * Altered mental status * Any pain that is considered to be not appropriate for receiving NSAIDS by emergency physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score at 30 minutes | 30 minutes post-administration | Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score at 15 minutes | 15 minutes post-administration | Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome) |
| Pain score at 45 minutes | 45 minutes post-administration | Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome) |
| Pain score at 60 minutes | 60 minutes post-administration | Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome) |
| Need for rescue analgesia | 30 minutes post-administration | IV morphine 0.1 mg/kg will be available at 30 minutes in cases of patients request |
| Side effects | From the drug administration to 60 minutes afterward | The patients will be assessed every 15 minutes for this outcome |
| Nasal irritation | 60 minutes after the drug administration | Nasal irritation will be assessed using a 3-level Likert-like scale, ranging from 1 to 3, where 1 = no nasal irritation, 2 = mild nasal irritation, and 3 = severe nasal irritation. Higher scores indicate greater nasal irritation (worse outcome). |
| Patient satisfaction score | 60 minutes after the drug administration | Patients will be asked to rate their satisfaction using a 5-level Likert-like scale, ranging from 1 to 5, where 1 = very dissatisfied and 5 = very satisfied. Higher scores indicate greater satisfaction (better outcome). |
Contacts
CONTACTHadi Mirfazaelian, MD
PRINCIPAL_INVESTIGATORHadi Mirfazaelian
Tehran University of Medical Sciences
Outcome results
None listed