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Phase 4 Completed N=135 Randomized Quadruple-blind Prevention

Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration

Fractures, Bone · Nausea and Vomiting, Postoperative · Pruritus · Morphine Adverse Reaction
Source: ClinicalTrials.gov NCT03035942 ↗
Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Quality of Recovery — 184; 187; 185 Score on a scale
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg), dexamethasone (8mg) or placebo.

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Recovery
184; 187; 185
SECONDARY
Nausea and Vomiting During PACU Staying
3; 9; 9
SECONDARY
Number of Participants With Pruritus
4; 7; 8
SECONDARY
Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)
0; 5; 2

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

Exclusion Criteria

Patients who:

(i) refused to participate in the study;

(ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;

(iii) presented with contraindication to any of the drugs used in the present study;

(iv) had history of alcohol or drug abuse and

(v) had surgery in the last 10 days were excluded.

Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03035942). 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. Informational only — not medical advice.

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