Acute Pain
Volume 9, Issue 4 , Pages 183-192, December 2007

Safety and efficacy of intranasal ketamine for acute postoperative pain

  • Kyle Christensen

      Affiliations

    • Wasatch Oral Surgery, 1268 West South Jordan Parkway, South Jordan, UT 84095, United States
  • ,
  • Elizabeth Rogers

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Geoff A. Green

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Douglas A. Hamilton

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Fred Mermelstein

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Edward Liao

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Curtis Wright

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
  • ,
  • Daniel B. Carr

      Affiliations

    • Javelin Pharmaceuticals, Inc., 125 CambridgePark Drive, Cambridge, MA 02140, United States
    • Corresponding Author InformationCorresponding author. Tel.: +1 617 349 4515; fax: +1 617 349 4505.

Received 7 March 2007; received in revised form 21 August 2007; accepted 25 September 2007.

Summary 

Background

Subanaesthetic doses of ketamine are analgesic. Intranasal administration offers a non-invasive route for systemic drug delivery. We evaluated the safety and analgesic efficacy of intranasal ketamine in treating moderate-to-severe, acute postoperative pain in the molar extraction model.

Methods

Intranasal ketamine (10mg, 30mg, and 50mg) and placebo were evaluated in a randomised, double-blind, single-dose, parallel study in 40 patients undergoing removal of 2–4 impacted third molars. Analgesic efficacy was assessed over a 3h period following drug administration. Safety was evaluated through adverse event reporting, vital signs, pulse oximetry, nasal assessments, and a standard dissociative side effects questionnaire.

Results

Ketamine delivered intranasally was well tolerated. Statistically significant analgesia, superior to placebo, was observed with the highest dose tested, 50mg, over a 3h period. Rapid onset of analgesia was reported (<10min), and meaningful pain relief was achieved within 15min of the 50mg dose. The majority of adverse events were mild/weak and transient. No untoward effects were observed on vital signs, pulse oximetry, and nasal examination. At the doses tested, no significant dissociative effects were evident using the Side Effects Rating Scale for Dissociative Anaesthetics.

Conclusion

Intranasal ketamine may offer a safe, nonopioid, well-tolerated, needle-free analgesic with efficacy in moderate-to-severe acute pain.

Keywords: Intranasal administration, Ketamine, Analgesia, Postoperative pain, Dental pain

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PII: S1366-0071(07)00167-2

doi:10.1016/j.acpain.2007.09.001

Acute Pain
Volume 9, Issue 4 , Pages 183-192, December 2007