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Postcraniotomy Pain | Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

Postcraniotomy Pain research study

What is the primary objective of this study?

The efficacy of codeine is dependent on its demethylation to morphine. This extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors. Codeine has been the mainstay of analgesia for patients after craniotomy for many years. Traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine). However, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction. No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine. Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.

Who is eligible to participate?

Inclusion Criteria: - Ages 21-70 years of age - Planned elective craniotomy - ASA 1-3 - GCS 15 pre and post-op - Able to understand and use the visual analogue scale Exclusion Criteria: - Patients with GCS < 15 pre and/or post-op. - Patients who are unable to quantify pain according to VAS scale. - Patients who will be left intubated post-op. - Contraindications and/or allergies to any of the trial drugs. - Patients with renal and/or hepatic impairment. - Patients with decreased respiratory reserves. - Patients with post-op cognitive dysfunction.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postcraniotomy Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:OxycodoneOral Oxycodone 5mg 6hrly/prn

Drug:CodeineOral Codeine 60mg 6hrly/prn

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CodeineOral Codeine 60mg 6hrly/prn

OxycodoneOral Oxycodone 5mg 6hrly/prn

Study Status

Completed

Start Date: July 2012

Completed Date: January 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.

Secondary Outcome: To look at the incidence of adverse events in the oxycodone and codeine groups.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Tan Tock Seng Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01672112

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