RecruitingPhase 4ACTRN12616000919415

Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study


Sponsor

Royal Perth Hospital

Enrollment

40 participants

Start Date

Apr 23, 2015

Study Type

Interventional

Conditions

Summary

The aim of this project is to show whether if there is a difference in the length of hospital stay and effect on health economics for patients who are using ‘patient controlled analgesics’ (PCA) compared to those patients who are on conventional oral or intravenous pain relief administered by nurse. The significance of this project is that, if there is a difference between the two groups, PCA and conventional pain relief group, this can help improve the cost of service to the patient. Reduced length of hospital stay means earlier discharge for the patients to their own environment for recovery and prevents nosocomial infections, this will also free up hospital bed for other patients and reduce the cost of administering PCA. The research question is whether there is a difference in the length of hospital stay for patients who are using PCA compared to conventional analgesics after orthognathic jaw surgery. Our hypothesis is that, those patients who are on PCA will have prolonged hospital stay compared to those who are on conventional oral or intravenous analgesics.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for patients who are having jaw realignment surgery (called orthognathic surgery). After this type of surgery, patients need pain relief. Some patients use a device they control themselves — called a patient-controlled analgesic (PCA) pump — while others receive pain medicine given by a nurse. This pilot study looks at whether one method leads to a shorter or longer hospital stay. You may be eligible if: - You are 16 years of age or older - You are scheduled for orthognathic (jaw) surgery - You are generally healthy with no significant heart, breathing, or chronic pain problems - You are not currently taking regular pain medicine for chronic conditions You may NOT be eligible if: - You are classified as ASA 3, 4, or 5 (meaning you have significant ongoing health problems) - You have chronic pain or fibromyalgia - You have a syndrome that complicates your care Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group. The exposure group will be administered a Patient Controlled Analgesics (PCA) o

Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group. The exposure group will be administered a Patient Controlled Analgesics (PCA) on top of their regular pain relief. The patients in the PCA group will follow the PCA protocol of 100microgram of fentanyl per delivery with a lock out time of 5 minutes. The patient will be given a push button which is connected to the PCA machine. At each press of the button, the machine will deliver 100micrograms of fentanyl. with a lock out time of 5 minutes. This means that patient will receive 12 doses of 100 micrograms of fentanyl per hour. There are no limits on the dosing per day. The regular pain medications will be Paracetamol 1g every 6 hours, Ibuprofen 400mg every 6 hours or Celebrex 100mg every 12 hours. These medications will be given as tablets. The PCA and oral pain relief will be administered until patient is discharged


Locations(2)

Royal Perth Hospital - Perth

WA, Australia

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12616000919415