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NCT05708521
Personalization of Opioid Prescription Following Orthognathic Surgery
Phase 4 trial testing Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery in Pain, Postoperative in 201 participants. Participants enrolled and being followed up; not accepting new ones.
30 May 2024
Quick facts
| Lead sponsor | Nova Scotia Health Authority |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 201 |
| Start date | 24 April 2023 |
| Primary completion | 30 May 2024 |
| Estimated completion | 1 May 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery
- Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery — full drug profile →
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Orthognathic Surgery — all drugs for Orthognathic Surgery →
- Opioid Use — all drugs for Opioid Use →
- Patient Satisfaction — all drugs for Patient Satisfaction →
Sponsor
Nova Scotia Health Authority — full company profile →
Who can join
Eligibility, any sex, with Pain, Postoperative or Orthognathic Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner. The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders. Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used. The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05708521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05708521 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nova Scotia Health Authority
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05708521.
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