A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132794
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : June 16, 2010
Information provided by:
The University of Hong Kong

Brief Summary:

Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation.

Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. The oldest, safest and most convenient route at present is the oral route. However, as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in problems like delayed effect. Intranasal administration is a straightforward procedure. It is simple and relatively painless. Although it may be objectionable, less patient cooperation is required than with oral administration, especially in which the child must swallow the medication.

Many studies on dental sedation have been carried out by anesthesiologists but there is no ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is the traditional choice for sedation, but it has properties such as relatively slow onset and no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and offset. It has been used in patient controlled sedation before. But it has no analgesic properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented with narcotics and benzodiazepines. Although not irritant, it can cause pain during intravenous infusion.

A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may lead to more potent effects of both sedation and analgesia without unwanted cardiovascular effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in broader patient populations. In the studies that have been completed to date, sedation has been attained easily with maintenance of respiratory function. Patients are readily arousable. There is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. So many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.

The investigators propose that intranasal can help to improve postoperative pain relief with better sedation.

Condition or disease Intervention/treatment Phase
Pain Sedation Drug: Intranasal dexmedetomidine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Intranasal nasal saline
Drug: Placebo
Intranasal nasal saline

Active Comparator: Dexmedetomidine
Intranasal dexmedetomidine
Drug: Intranasal dexmedetomidine
1mcg per kg dexmedetomidine given intranasally 45 minutes before operation

Primary Outcome Measures :
  1. Pain scores after operation

Secondary Outcome Measures :
  1. Sedation satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) 1 or 2
  • Age >18 and less than 40 years
  • Unilateral wisdom tooth removal
  • Written informed consent

Exclusion Criteria:

  • Allergy to dexmedetomidine and propofol
  • Patient refusal
  • Mentally unfit
  • Impaired renal or hepatic function
  • Pregnant
  • Exposure to study drug within the past 3 months.
  • Use ofα2 agonists currently
  • Patients with cardiac disease
  • Abnormal electrocardiogram
  • Inability to complete psychomotor test
  • Addictive in illicit drugs or alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132794

Hong Kong
Department of Anaesthesiology, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong Identifier: NCT01132794     History of Changes
Other Study ID Numbers: 200707176037
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: May 2010

Keywords provided by The University of Hong Kong:
Pain relief and sedation condition

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action