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Trial record 53 of 448 for:    diphenhydramine

Effects of Intravenous Lidocaine on Endometriosis Pain

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ClinicalTrials.gov Identifier: NCT01968694
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Antje Barreveld, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Endometriosis
Interventions Drug: IV Lidocaine
Drug: IV diphenhydramine
Enrollment 20
Recruitment Details  
Pre-assignment Details Only 19 of the 20 enrolled started the study because one participant did not participate past consent.
Arm/Group Title IV Lidocaine Then IV Diphenhydramine IV Diphenhydramine Then IV Lidocaine
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IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.

IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.

Period Title: Visit 1 (1 Day)
Started 10 9
Completed 10 9
Not Completed 0 0
Period Title: Washout (1 Month)
Started 10 9
Completed 10 8
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Visit 2 (1 Day)
Started 10 8
Completed 10 8
Not Completed 0 0
Arm/Group Title IV Lidocaine Then IV Diphenhydramine IV Diphenhydramine Then IV Lidocaine Total
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IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.

IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.

Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
10
 100.0%
9
 100.0%
19
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Change in Visual Analogue Scale (VAS)
Hide Description

Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).

Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:

(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)

Time Frame 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
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Hide Analysis Population Description

2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started.

3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete.

Arm/Group Title IV Lidocaine IV Diphenhydramine
Hide Arm/Group Description:
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Overall Number of Participants Analyzed 18 19
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
15 minutes after start of infusion change Number Analyzed 18 participants 19 participants
-2.6
(-4.5 to -0.8)
-0.2
(-1.0 to 0)
30 minutes after start of infusion change Number Analyzed 17 participants 19 participants
-3.5
(-5.0 to -2.3)
-1.5
(-2.7 to -0.1)
30 minutes after infusion complete change Number Analyzed 15 participants 19 participants
-3.6
(-4.6 to -0.6)
-1.7
(-2.7 to 0)
2.Secondary Outcome
Title Change in Short Form McGill Pain Questionnaire 2
Hide Description

Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.

Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:

(30 minutes post-treatment value - BL pre-infusion value)

(1 week post-treatment value - BL pre-infusion value)

(1 month post-treatment value - BL pre-infusion value)

Time Frame 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
  1. participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment.
  2. participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment.
  3. participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment.
Arm/Group Title IV Lidocaine IV Diphenhydramine
Hide Arm/Group Description:
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Overall Number of Participants Analyzed 18 19
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
30 minutes change from BL Number Analyzed 18 participants 19 participants
-14.5
(-46 to -8)
-15
(-30 to -4)
1 week change from BL Number Analyzed 18 participants 18 participants
-18
(-43 to -4)
-17
(-30 to -6)
1 month change from BL Number Analyzed 15 participants 17 participants
4
(-35 to 24)
-18
(-26 to -11)
3.Secondary Outcome
Title Change in Brief Pain Inventory (BPI): Pain on Average
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The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.

Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:

(1 day post-treatment value - BL pre-infusion value)

(1 week post-treatment value - BL pre-infusion value)

(1 month post-treatment value - BL pre-infusion value)

Time Frame 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month.
Arm/Group Title IV Lidocaine IV Diphenhydramine
Hide Arm/Group Description:
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Overall Number of Participants Analyzed 17 19
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1 day change from BL Number Analyzed 17 participants 19 participants
-2
(-3 to 0)
0
(-2 to 1)
1 week change from BL Number Analyzed 17 participants 18 participants
-2
(-2 to 0)
0
(-1 to 0)
1 month change from BL Number Analyzed 14 participants 17 participants
-1
(-2 to 0)
-1
(-1 to 1)
4.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scale (HADS)
Hide Description

The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.

A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).

Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:

(1 day post-treatment value - BL pre-infusion value)

(1 week post-treatment value - BL pre-infusion value)

(1 month post-treatment value - BL pre-infusion value)

Time Frame 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month.
Arm/Group Title IV Lidocaine IV Diphenhydramine
Hide Arm/Group Description:
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Overall Number of Participants Analyzed 18 19
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Anxiety 1 day change Number Analyzed 18 participants 19 participants
-1
(-2 to 0)
0
(-2 to 0)
Anxiety 1 week change Number Analyzed 18 participants 18 participants
-1
(-2 to -1)
-2
(-3 to 0)
Anxiety 1 month change Number Analyzed 15 participants 16 participants
0
(-2 to 0)
-1.0
(-2.5 to 0)
Depression 1 day change Number Analyzed 18 participants 19 participants
-0.5
(-2.0 to 0)
0
(-2 to 0)
Depression 1 week change Number Analyzed 18 participants 18 participants
-1
(-2 to -1)
-2
(-3 to 0)
Depression 1 month change Number Analyzed 15 participants 16 participants
-1
(-2 to 0)
-0.5
(-3 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Lidocaine IV Diphenhydramine Washout Period After IV Lidocaine Washout Period After IV Diphenhydramine
Hide Arm/Group Description IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes Washout period after IV Lidocaine before IV diphenhydramine Washout period after IV diphenhydramine before IV Lidocaine
All-Cause Mortality
IV Lidocaine IV Diphenhydramine Washout Period After IV Lidocaine Washout Period After IV Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Lidocaine IV Diphenhydramine Washout Period After IV Lidocaine Washout Period After IV Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%)   0/10 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Lidocaine IV Diphenhydramine Washout Period After IV Lidocaine Washout Period After IV Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%)   0/10 (0.00%)   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Antje M Barreveld
Organization: Brigham & Women's Hospital
Phone: 617-243-6298
Responsible Party: Antje Barreveld, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01968694     History of Changes
Other Study ID Numbers: 2010P002903
First Submitted: October 21, 2013
First Posted: October 24, 2013
Results First Submitted: May 11, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017