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Completed

NCT Number: NCT01672112

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

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.

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Key information

Conditions

Postcraniotomy Pain

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tan Tock Seng Hospital

Singapore, 308433

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone

Drug

Oral Oxycodone 5mg 6hrly/prn

Other names: Oxynorm Immediate Release

Codeine

Drug

Oral Codeine 60mg 6hrly/prn

Other names: Codeine Phosphate

Primary outcomes

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

    Time frame: 24hr post-op.

Secondary outcomes

  1. To look at the incidence of adverse events in the oxycodone and codeine groups.

    Time frame: Up to 72hrs post-op.

    To compare the incidence of excessive sedation, respiratory depression and GCS; to compare the pain VAS scores at 48 and 72hrs post-op; to compare the mean satisfaction scores at 24 and 72hrs post-op.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2012
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.