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Study protocol
Xianyou Zheng
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9770-5394
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (10 mg)/acetaminophen (650 mg), and the control group will receive acetaminophen (650 mg) only. All participants will be instructed to take one pill of study medication on an as-needed basis and no more frequently than once every 8 hours. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial registration numbers: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018.
Keywords
Opioids, acetaminophen, fracture, nonoperative treatment
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CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 05 Jun, 2019
No community comments so far
Editorial decision: Accept
On 16 Jul, 2019
Review #1 received
Received 18 Jun, 2019
Submission checks complete
On 12 Jun, 2019
Editor assigned
On 12 Jun, 2019
Reviewers invited
Invitations sent on 12 Jun, 2019
Reviewer #1 agreed
On 12 Jun, 2019
No comments provided
Review #1 received
Received 28 May, 2019
Editorial decision: Major revision
On 28 May, 2019
Reviewer #1 agreed
On 17 May, 2019
Submission checks complete
On 16 May, 2019
Editor assigned
On 16 May, 2019
Reviewers invited
Invitations sent on 16 May, 2019
No comments provided
Editorial decision: Minor revision
On 23 Apr, 2019
Review #2 received
Received 22 Apr, 2019
Reviewer #2 agreed
On 12 Apr, 2019
Review #1 received
Received 11 Apr, 2019
Reviewer #1 agreed
On 25 Mar, 2019
Reviewers invited
Invitations sent on 21 Mar, 2019
Editor assigned
On 20 Mar, 2019
First submitted
On 07 Feb, 2019
Submission checks complete
On 07 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Xianyou Zheng
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9770-5394
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 05 Jun, 2019
No community comments so far
Editorial decision: Accept
On 16 Jul, 2019
Review #1 received
Received 18 Jun, 2019
Submission checks complete
On 12 Jun, 2019
Editor assigned
On 12 Jun, 2019
Reviewers invited
Invitations sent on 12 Jun, 2019
Reviewer #1 agreed
On 12 Jun, 2019
No comments provided
Review #1 received
Received 28 May, 2019
Editorial decision: Major revision
On 28 May, 2019
Reviewer #1 agreed
On 17 May, 2019
Submission checks complete
On 16 May, 2019
Editor assigned
On 16 May, 2019
Reviewers invited
Invitations sent on 16 May, 2019
No comments provided
Editorial decision: Minor revision
On 23 Apr, 2019
Review #2 received
Received 22 Apr, 2019
Reviewer #2 agreed
On 12 Apr, 2019
Review #1 received
Received 11 Apr, 2019
Reviewer #1 agreed
On 25 Mar, 2019
Reviewers invited
Invitations sent on 21 Mar, 2019
Editor assigned
On 20 Mar, 2019
First submitted
On 07 Feb, 2019
Submission checks complete
On 07 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (10 mg)/acetaminophen (650 mg), and the control group will receive acetaminophen (650 mg) only. All participants will be instructed to take one pill of study medication on an as-needed basis and no more frequently than once every 8 hours. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial registration numbers: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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