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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01132794
First received: May 24, 2010
Last updated: June 15, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Pain
Sedation
Drug: Intranasal dexmedetomidine
Drug: Placebo
Phase 3

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Pain scores after operation

Secondary Outcome Measures:
  • Sedation satisfaction

Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132794

Locations
Hong Kong
Department of Anaesthesiology, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01132794     History of Changes
Other Study ID Numbers: 200707176037
Study First Received: May 24, 2010
Last Updated: June 15, 2010
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on July 23, 2014