N/A
N=402
Satisfactory Analgesia Minimal Emesis in Day Surgeries
Pain · Post Operative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02223377 ↗Enrolled (actual)
402
Serious AEs
5.2%
Results posted
Dec 2023
Primary outcome: Primary: Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups. — 172; 175 Participants — p=0.997
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morphine (Drug); Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups. |
172; 175 | 0.997 |
| SECONDARY Number of Patients With Severe Itching |
2; 5 | — |
| SECONDARY Severe Sedation |
5; 8 | — |
| SECONDARY Severe Respiratory Depression |
11; 10 | — |
| SECONDARY Patients Requesting Oral Analgesia in the Day Surgery Unit |
128; 135 | — |
| SECONDARY Mean Dose of Analgesic Used |
5.7; 4.9 | 0.040 sig |
| SECONDARY Patient Satisfaction Score |
9.1; 9.3 | — |
| SECONDARY Time to Discharge From PACU |
91.2; 92.8 | — |
| SECONDARY Time to Discharge From Hospital |
3.2; 3.3 | — |
Summary
Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as they offer significant benefit to the patients as well as to the hospitals. Inadequate pain relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain, but can also cause significant nausea-vomiting and other side effects. Although hydromorphone is five times more potent than morphine, in equianalgesic doses they both could provide similar pain relief. They both exert no ceiling effect for their analgesia, and hence incomplete or inadequate analgesia is related to the appearance of side effects. In this study the investigators shall assess the proportion of patients who satisfy the outcome of 'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2 hours after surgery. Patients would be randomized to receive either morphine or hydromorphone in the surgical recovery area. All personnel involved with the study would be blinded. The investigators will also look to assess the time to discharge and other side effects. This will help to choose the better drug, thereby improving pain relief and side effects, and also the efficiency of health care delivery.
Eligibility Criteria
Inclusion Criteria
- ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
- ability to communicate in English.
Exclusion Criteria
- allergy to M or HM
- patient on regular chronic opioid medication
- patient uncontrolled systemic disease
- severe obesity with a BMI >35
- significant psychological impairment
- history of drug addiction or dependence
- any planned regional or nerve block other than local anesthesia infiltration patients with confirmed sleep apnea
- emergency surgeries and urological surgeries
Data sourced from ClinicalTrials.gov (NCT02223377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.