Trial · NCT01200069
IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
NCT01200069, Phase 4, Terminated, Rutgers, The State University of New Jersey; results first posted 2016-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia. Trials, record NCT01200069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01200069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
- NCT number
- NCT01200069
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 14 participants, actual
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Depression, Myalgia
- Interventions
- Placebo infusion, ibuprofen intravenous
- First posted
- 2010-09-13
- Last updated
- 2017-03-29
- Results first posted
- 2016-11-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours | subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL |
| Primary | Myalgia Reported on Treatment Day 2 | 1 hour, 6 hours, 24 hours & 48 hours following procedure | Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities) |
| Primary | Myalgia Reported After Treatment #3 | 1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment | Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities) |
| Secondary | Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1 | 1 hour, 6 hours, 24 hours & 48 hours following procedure | Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain |
| Secondary | Incidence and Severity of Headache After ECT Treatment 2 | 1 hour, 6 hour, 24 hour and 48 hours | Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain. |
| Secondary | Incidence of Headache & Severity Headache After ECT Treatment #3 | 1 hour after treatment, 6 hours, 24 hours and 48 hours | Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours | subjects report at one hour following treatment | units on a scale | MEDIAN |
| PRIMARY | Myalgia Reported on Treatment Day 2 | 1 hour, 6 hours, 24 hours & 48 hours following procedure | units on a scale | MEDIAN | |
| PRIMARY | Myalgia Reported After Treatment #3 | 1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment | units on a scale | MEDIAN | |
| SECONDARY | Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1 | 1 hour, 6 hours, 24 hours & 48 hours following procedure | units on a scale | MEAN | |
| SECONDARY | Incidence and Severity of Headache After ECT Treatment 2 | 1 hour, 6 hour, 24 hour and 48 hours | units on a scale | MEAN | |
| SECONDARY | Incidence of Headache & Severity Headache After ECT Treatment #3 | 1 hour after treatment, 6 hours, 24 hours and 48 hours | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Sugar Water-one Hour After Treatment #1 | 2 | Full Range 0 to 4 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Ibuprofen One Hour After Treatment #1 | 0 | Full Range 0 to 0 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Sugar Water 6 Hours After Procedure #1 | 7.5 | Full Range 5 to 10 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Ibuprofen 6 Hours After Treatment #1 | 1.5 | Full Range 0 to 3 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Sugar Water 24 Hours After Treatment #1 | 2.5 | Full Range 2 to 5 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Ibuprofen 24 Hours After Treatment 1 | .5 | Full Range 0 to 1 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Sugar Water 48 Hours After Procedure 1 | 0 | Full Range 0 to 0 | units on a scale | |
| Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1 | Ibuprofen 48 Hours After Treatment 1 | 0 | Full Range 0 to 0 | units on a scale | |
| Myalgia Reported on Treatment Day 2 | Sugar Water-one Hour After Treatment 2 | 1.5 | Full Range 0 to 3 | units on a scale | |
| Myalgia Reported on Treatment Day 2 | Ibuprofen One Hour After Treatment #2 | 0 | Full Range 0 to 0 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sugar Water | 8 | |
| Overall Study | STARTED | Ibuprofen | 6 | |
| Overall Study | COMPLETED | Sugar Water | 8 | |
| Overall Study | COMPLETED | Ibuprofen | 5 | |
| Overall Study | NOT COMPLETED | Sugar Water | 0 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | dizzyness | Nervous system disorders | Sugar Water | 2 | 8 | |
| other | dizzyness | Nervous system disorders | Ibuprofen | 0 | 6 | |
| other | vomiting | Gastrointestinal disorders | Sugar Water | 0 | 8 | |
| other | vomiting | Gastrointestinal disorders | Ibuprofen | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sugar Water | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, other adverse events | Sugar Water | 2 | 8 |
| Total, other adverse events | Ibuprofen | 1 | 6 |
| Total, serious adverse events | Sugar Water | 0 | 8 |
| Total, serious adverse events | Ibuprofen | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sugar Water vs Ibuprofen: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01200069
GET https://conductscience.org/api/trials/v1/NCT01200069/results?page=2