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ebulized ketamine versus intravenous morphine for older adults with acute musculoskeletal pain in the emergency department: a randomized controlled trial

Phase 3
Conditions
1.Patients aged 65 and older, who presented to the ED with the chief complaint of musculoskeletal pain within 7 days.2.Pain score of 5 or more on a 11-point numeric rating scale [0 (no pain) to 10 (most severe pain)].
ketamine Nebulizer, older adults, pain management
Registration Number
TCTR20220719005
Lead Sponsor
AVAMINDRADHIRAJ UNIVERSITY RESEARCH FUND
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
nknown
Sex
All
Target Recruitment
98
Inclusion Criteria

1.Patients aged 65 and older, who presented to the ED with the chief complaint of musculoskeletal pain within 7 days.
2.Pain score of 5 or more on a 11-point numeric rating scale [0 (no pain) to 10 (most severe pain)].

Exclusion Criteria

1.Patients who had hemodynamic instability which were defined as systolic blood pressure < 90 or > 180 mmHg, heart rate < 50 or > 150 beats/min , respiratory rate < 10 or > 30 breaths /min.
2.Patients with comorbidities of coronary artery disease or congestive heart failure, psychological disorder or severe chronic obstructive pulmonary disease.
3.Patient with chronic pain
4.History of traumatic brain or eye injury.
5.History of seizure or intracranial hypertension.
6.History of morphine or ketamine allergy.
7.History of opioid used within 8 hours (e.g. tramadol, fentanyl , morphine, codeine, pethidine, methadone) or unknown drug used.)
8.History of alcohol or drug abuse.
9.Actual body weight < 40 kilogram (kg) or > 115 kg.
10.Creatinine clearance < 50 ml/min.
11.Hepatic insufficiency.
12.Patients who needed immediate surgical intervention.
13.Patients with difficulty to communication (e.g. altered mental status, severe dementia (define by 6-items cognitive screening > 12), language barrier).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
reduction of pain scores on a 11-point numeric rating scale between nebulized ketamine and intravenous morphine at baseline and 15, 30, 60, 90, and 120 minutes. at baseline and 15, 30, 60, 90, and 120 minutes. a 11-point numeric rating scale
Secondary Outcome Measures
NameTimeMethod
incidence of adverse events and the rate of rescue therapy. at baseline and 15, 30, 60, 90, and 120 minutes. anaphylaxis, cardiac arrest, intractable hypotension, hypersecretion or laryngospasm, Nausea Vomiting, Respiratory depression
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