Analgesia
Conditions
Brief summary
When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics. For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended. Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after. A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor. The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.
Interventions
DRUGCociane hydrochloride 4%
2 mL of 4% cocaine
DRUGLidocaine 4%
1.5 mL of 4% lidocaine
DRUGXylometazoline 0.1%
0.5 mL of xylometazoline 0.1%
DRUGSaline 0.9%
2 mL of saline 0.9%
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years * Proficient in spoken and written Danish * Healthy volunteers (no active diagnoses) * Negative hCG (human chorionic gonadotropin) urine stix for women of childbearing potential
Exclusion criteria
* Known nasal malformation * Known coagulopathy * Current antithrombotic treatment * Self-reported epistaxis occurring more than once a month * Symptoms of a common cold within the past week * Hypersensitivity to local anaesthetics of amide type or any of the excipients * Hypertension * Narrow-angle glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain regarding the procedure | Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube | Self reported pain on a visual analogue scale of 0-100 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume | 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration | Volume within both nasal cavities measured with acoustic rhinometry |
| Fiberoptic endoscopy | Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration | Preferred nasal cavity based on a comparison of the degree of vasoconstriction of the nasal mucosa evaluated by fiberoptic endoscopy assessed by ENT-specialist |
| Drug test detection | 15 minutes before drug administration and 1, 2 and 3 hours after drug administration | Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively |
| Pain regarding the procedure | One minute after the procedure of insertion of a 6.0 nasal endotracheal tube | Self reported pain on a visual analogue scale of 0-100 mm |
| Blood pressure | 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration | Measurement of mean arterial blood pressure |
| Patient-centred questions | 15 minutes after drug administration | The degree of discomfort and unpleasentness of taste of the drug administration on a scale of 1-10 and whether they felt exaltation after drug administration. |
| Heart rate | 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration | Measurement of heart rate |
Countries
Denmark
Outcome results
None listed