A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia
Condition: Pain; Sedation
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): Intranasal dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1mcg per kg dexmedetomidine given intranasally 45 minutes before operation; Intranasal nasal saline
Intervention MeSH terms: Dexmedetomidine
Keywords: Pain relief and sedation condition