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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000919415

Enrollment

Registered

2016-07-11

Start date

2015-04-23

Completion date

2017-08-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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) 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Sample group will be ASA 1 or 2 patients who have no significant prior medical problems (including any cardiac history, respiratory disease, chronic pain issues or on any regular pain relief for chronic pain or arthritic pains) and are having Orthognathic surgery will be recruited for this study. All ages and genders are included. They will be fully informed and given the option to agree or deny participation into the study and will be consented for this study.

Exclusion criteria

ASA 3, ASA 4, ASA 5 Chronic pain Fibromyalgia Syndromic

Outcome results