Trial Outcomes & Findings for IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia (NCT NCT01200069)
NCT ID: NCT01200069
Last Updated: 2017-03-29
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours
Results posted on
2017-03-29
Participant Flow
recruited following assigned schedule date and time for first ECT treatment, Procedure took place in Medical Special procedure unit (same day service)
Participant milestones
| Measure |
Sugar Water
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
|
Ibuprofen
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sugar Water
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
|
Ibuprofen
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
Baseline characteristics by cohort
| Measure |
Sugar Water
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
|
Ibuprofen
n=6 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Mini Mental State Examination >23
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hoursPopulation: subjects report at one hour following treatment
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
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=6 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=6 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=6 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=8 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=6 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1
|
2 units on a scale
Interval 0.0 to 4.0
|
0 units on a scale
Interval 0.0 to 0.0
|
7.5 units on a scale
Interval 5.0 to 10.0
|
1.5 units on a scale
Interval 0.0 to 3.0
|
2.5 units on a scale
Interval 2.0 to 5.0
|
.5 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 1 hour, 6 hours, 24 hours & 48 hours following procedureSubject 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)
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=5 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=5 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=5 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=8 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=5 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Myalgia Reported on Treatment Day 2
|
1.5 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
1.5 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatmentSubject 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)
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=5 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=5 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=5 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=8 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=7 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Myalgia Reported After Treatment #3
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 hour, 6 hours, 24 hours & 48 hours following procedureSubject 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
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=6 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=6 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=6 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=8 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=6 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1
|
2.6 units on a scale
Interval 0.0 to 6.0
|
1.5 units on a scale
Interval 0.0 to 5.0
|
3.1 units on a scale
Interval 3.0 to 10.0
|
1.3 units on a scale
Interval 0.0 to 4.0
|
3.6 units on a scale
Interval 0.0 to 5.0
|
.16 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 hour, 6 hour, 24 hour and 48 hoursSubject 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.
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=5 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=5 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=8 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=7 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=8 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Headache After ECT Treatment 2
|
1.4 units on a scale
Interval 0.0 to 5.0
|
1.1 units on a scale
Interval 0.0 to 4.0
|
1.55 units on a scale
Interval 0.0 to 5.0
|
1 units on a scale
Interval 0.0 to 5.0
|
.18 units on a scale
Interval 0.0 to 2.0
|
.14 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
.14 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 1 hour after treatment, 6 hours, 24 hours and 48 hoursSubject 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.
Outcome measures
| Measure |
Sugar Water-one Hour After Treatment #1
n=8 Participants
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
|
Ibuprofen One Hour After Treatment #1
n=5 Participants
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1
|
Sugar Water 6 Hours After Procedure #1
n=8 Participants
Subject reported myalgia 6 hours after completion of treatment # 1,
|
Ibuprofen 6 Hours After Treatment #1
n=5 Participants
subject reported myalgia 6 hours after treatment 1
|
Sugar Water 24 Hours After Treatment #1
n=8 Participants
subject reported myalgia 24 hours after completion of procedure 1
|
Ibuprofen 24 Hours After Treatment 1
n=5 Participants
subject reported myalgia 24 hours after procedure 1
|
Sugar Water 48 Hours After Procedure 1
n=8 Participants
subject reported myalgia 48 hours after procedure 1
|
Ibuprofen 48 Hours After Treatment 1
n=5 Participants
subject reported myalgia 48 hours after treatment day 1
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Headache & Severity Headache After ECT Treatment #3
|
0 units on a scale
Interval 0.0 to 0.0
|
.64 units on a scale
Interval 0.0 to 4.0
|
.28 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 6.0
|
0 units on a scale
Interval 0.0 to 0.0
|
.16 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Sugar Water
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Water
n=8 participants at risk
500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
|
Ibuprofen
n=6 participants at risk
800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
|
|---|---|---|
|
Nervous system disorders
dizzyness
|
25.0%
2/8 • 0-72 hours after each of the 3 treatments
treatment day 1 at 1 hour post ECT procedure subject experienced dizziness treatment day 3 at 6 hour post procedure subject reported dizziness
|
0.00%
0/6 • 0-72 hours after each of the 3 treatments
treatment day 1 at 1 hour post ECT procedure subject experienced dizziness treatment day 3 at 6 hour post procedure subject reported dizziness
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/8 • 0-72 hours after each of the 3 treatments
treatment day 1 at 1 hour post ECT procedure subject experienced dizziness treatment day 3 at 6 hour post procedure subject reported dizziness
|
16.7%
1/6 • 0-72 hours after each of the 3 treatments
treatment day 1 at 1 hour post ECT procedure subject experienced dizziness treatment day 3 at 6 hour post procedure subject reported dizziness
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place