NCT05277038

Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Salem Anaesthesia Pain Clinic · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

Summary

A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.

Detailed description

Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine; for the management of insomnia in patients with chronic pain. Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 was considered significant.

Conditions

• Insomnia Chronic
• Pain, Chronic

Interventions

Type	Name	Description
DRUG	Clonidine 0.1mg pill	Routine prescription for insomnia
DRUG	Clonidine 0.2mg pill	Routine prescription for insomnia
DRUG	Zopiclone 3.75mg pill	Routine prescription for insomnia
DRUG	Zopiclone 7.5mg pill	Routine prescription for insomnia

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-11-05
• Completion: 2022-11-05
• First posted: 2022-03-14
• Last updated: 2022-11-18

Locations

1 site across 1 country: Canada