The pharmacokinetics of intranasal droperidol in healthy volunteers.
A randomised cross-over study comparing the pharmacokinetics of intranasal droperidol to intravenous droperidol in healthy volunteers:
Monash Health
7 participants
Dec 15, 2014
Interventional
Conditions
Summary
The intranasal (IN) route of drug administration has many advantages. It has the potential to eliminate the pain, anxiety, and distress that can be associated with the use of needles for IV or IMI drug delivery. The risk of needle-stick injury and blood-borne infection is also minimized by the use of needleless systems. In addition, drug administration can occur more quickly than intravenous administration as there is no need to spend time siting a cannula and there is reduced resource utilisation. Recent observational research in the ED setting has revealed that more than 50% of inserted intravenous cannulae are never used for therapeutic purposes and pose a significant risk for skin infection and septicaemia if left in-situ. There is currently no data examining the pharmacokinetic profile of intranasal droperidol. However, based upon results with intranasal haloperidol, it is likely that droperidol, having similar pharmacokinetic properties, may display a comparable intranasal absorption profile. Currently, there are no anti-emetics or antipsychotic medications being administered intranasally in the clinical setting. As a result, if the pharmacokinetic profile is favourable, droperidol may be a useful drug to consider for clinical trials of intranasal treatment of acute behavioural disturbance and anti-emesis.
Eligibility
Inclusion Criteria2
- Healthy adult males aged between 18 and 55 years
- Body weight > 50kg and < 100 kg with BMI < 28
Exclusion Criteria12
- Female gender
- Allergy to droperidol
- Previous history of any dystonic reaction to medications
- Abnormal nasal anatomy
- Previous nasal surgery or nasal trauma that may interfere with administration of absorption of intranasal medication
- Current or recent upper respiratory tract infection
- Use of any prescription or non-prescription drugs that may affect droperidol metabolism or nasal physiology (vasoconstrictors e.g. phenylephrine) within the past seven days
- Treatment with medication known to prolong the QT interval
- Absolute QT calculated as the average of three limb lead and three chest lead (V2-V4) QT interval duration.
- Abnormal 12-lead ECG on screening with QTcorrected> 480 msec using Sagie regression QTc calculation formula and correlated with Isbister QT-heart rate pair nomogram.
- Any known cardiovascular, gastrointestinal, pulmonary, renal, haematologic or liver disease
- Any psychiatric or mental health disorder or previous history of antipsychotic medication use
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Interventions
Intranasal administration of droperidol 0.02mg/kg as a single dose with 1 week wash out between study arms.
Locations(1)
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ACTRN12614000514606