Study group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days

Study group 2 CLP with ostectomy Diclofenac Sodium 50mg twice daily after meals with plain water

Study group 3 CLP with ostectomy Placebo pills and distilled water 3 pills,3 times daily

Crown Lengthening Procedure With Ostectomy

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Arnica 200 drug 3 pills,3 times daily for 3 days

Diclofenac Sodium 50mg twice daily

Placebo pills and distilled water 3 pills,3 times daily

Dental

Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure

Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure: A Placebo Control Trial

Pain Assessment is done by visual analog scale which consists of 10 centimeter line. anchored by two extremes starting from 1 ending to 10, of which 1 being the lowest and 10 being highest score.

Dr.Nibha Suneel Kulkarni

Principal Investigator

Tatyasaheb Kore Dental College

500 milliliters of intravenous ringers lactate administered over 30 minutes prior to ECT for treatments 1,2 and 3

300mg/8milliliters of intravenous ibuprofen/caldolor over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3

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

Sugar Water

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

Ibuprofen

Total

Sex: Female, Male

Region of Enrollment

examination of participants to confirm cognitive ability. Questions such as who is the president, what is the day of the week, the date. The scale is from 0-30. Value of 24 or higher indicates absence of cognitive impairment

Mini Mental State Examination >23

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

500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure

Sugar Water-one Hour After Treatment #1

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

Ibuprofen One Hour After Treatment #1

Subject reported myalgia 6 hours after completion of treatment # 1,

Sugar Water 6 Hours After Procedure #1

subject reported myalgia 6 hours after treatment 1

Ibuprofen 6 Hours After Treatment #1

subject reported myalgia 24 hours after completion of procedure 1

Sugar Water 24 Hours After Treatment #1

subject reported myalgia 24 hours after procedure 1

Ibuprofen 24 Hours After Treatment 1

subject reported myalgia 48 hours after procedure 1

Sugar Water 48 Hours After Procedure 1

subject reported myalgia 48 hours after treatment day 1

Ibuprofen 48 Hours After Treatment 1

Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1

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)

500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2

Sugar Water-one Hour After Treatment 2

800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2

Ibuprofen One Hour After Treatment #2

Subject reported myalgia 6 hours after completion of treatment #2

Sugar Water 6 Hours After Procedure #2

Ibuprofen 6 Hours After Treatment #2

Subject reported myalgia 24 hours after completion of treatment #2

Sugar Water 24 Hours After Treatment #2

Ibuprofen 24 Hours After Treatment #2

Subject reported myalgia 48 hours after completion of treatment #2

Sugar Water 48 Hours After Treatment 2

Ibuprofen 48 Hours After Treatment 2

Myalgia Reported on Treatment Day 2

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)

500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2

Sugar Water-one Hour After Treatment 3

800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2

Ibuprofen One Hour After Treatment #3

Subject reported myalgia 6 hours after completion of treatment #3

Sugar Water 6 Hours After Procedure #3

Ibuprofen 6 Hours After Treatment #3

Subject reported myalgia 24 hours after completion of treatment #3

Sugar Water 24 Hours After Treatment #3

Ibuprofen 24 Hours After Treatment #3

Subject reported myalgia 48 hours after completion of treatment #3

Sugar Water 48 Hours After Treatment 3

Ibuprofen 48 Hours After Treatment 3

Myalgia Reported After Treatment #3

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

500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1

Pain Score Sugar Water-one Hour After Treatment 1

800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2

Pain Score Ibuprofen One Hour After Treatment #1

Subject reported headache 6 hours after completion of treatment #1

Pain Score After Sugar Water 6 Hours After Treatment #1

Pain Score Ibuprofen 6 Hours After Treatment #1

Subject reported headache 24 hours after completion of treatment #1

Pain Score Sugar Water 24 Hours After Treatment #1

Subjects reported headache 24 hours after completion of treatment #1

Pain Score Ibuprofen 24 Hours After Treatment #1

Subjects reported headache 48 hours after completion of treatment #1

Pain Score Sugar Water 48 Hours After Treatment 1

Pain Score Ibuprofen 48 Hours After Treatment 1

Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1

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.

800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments #2 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2

Subject reported headache 6 hours after completion of treatment #2

Subject reported headache 24 hours after completion of treatment #2

Subject reported headache 48 hours after completion of treatment #2

Sugar Water 48 Hours After Treatment #2

Ibuprofen 48 Hours After Treatment #2

Incidence and Severity of Headache After ECT Treatment 2

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.

Subject reported headache 6 hours after completion of treatment #3

Subject reported headache 24 hours after completion of treatment #3

Subject reported headache 48 hours after completion of treatment #3

Incidence of Headache & Severity Headache After ECT Treatment #3

Overall Study

Vasanti Tilak, MD

Depression, Myalgia

Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3

Placebo infusion

IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3

ibuprofen intravenous

University Hospital

IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

Intravenous Ibuprofen/Caldolor for Post-Electroconvulsive Therapy Myalgia

Rutgers, The State University of New Jersey

Twenty participants will receive a blood transfusion while in the hospital.

Twenty participants will not receive a blood transfusion and will receive standard care.

Approximately 300 participants who are ineligible for or decline the blood transfusion part of the study will participate in the observational portion of the study and receive standard care.

237 subjects enrolled in the feasibility study.

All Participants

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Maximum secretory phospholipase A2 (sPLA2) value measured prior to acute chest syndrome (ACS) or discharge

Maximum secretory phospholipase A2 (sPLA2) value

First occurence of positive infiltrate on chest x-ray

Adults

Children

Overall

Acute Chest Syndrome

Subjects received a transfusion within 6 hours of randomization.

Blood Transfusion Trial Cohort

Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.

Standard Care Trial Cohort

Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).

Standard Care Observational Cohort

Hae-Young Kim

Sickle Cell Disease

Participants will receive a single transfusion of 7-13cc/kg packed red blood cells (RBCs) while in the hospital.

Single blood transfusion

Participants will receive standard care for ACS while in the hospital.

Standard care

Children's Hospital and Research Center

A.I. duPont Hospital for Children

Children's National Medical Center

Howard University Hospital

Emory University School of Medicine

Medical College of Georgia

Children's Memorial Hospital

University of Illinois Sickle Cell Center

Kosair Children's Hospital

Johns Hopkins

Boston Medical Center

Brigham & Women's Hospital

Children's Hospital Boston

University of Mississippi Medical Center

Interfaith Medical Center

New York Methodist Hospital

The University of North Carolina at Chapel Hill

Duke University Medical Center

Cincinnati Children's Hospital Medical Center

Nationwide Children's Hospital

Ohio State University

Children's Hospital of Philadelphia

St. Christopher's Hospital for Children

Virginia Commonwealth University Health Systems

Preventing Acute Chest Syndrome by Transfusion Feasibility Study

Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)

HealthCore-NERI

National Heart, Lung, and Blood Institute (NHLBI)

Vaso-occlusive Crisis

A-001

Placebo

Children's Healthcare of Atlanta

SUNY Downstate Medical Center

Duke University Comprehensive Sickle Cell Center

Virginia Commonwealth University

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome (Dose Escalation Study: Varespladib Infusion [A-001] for the Prevention of Acute Chest Syndrome in At-Risk Patients With Sickle Cell Disease and Vaso-occlusive Crisis)

phospholipase/חום

Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure

IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

Preventing Acute Chest Syndrome by Transfusion Feasibility Study

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

המאגר השלם ביותר של צמחי מרפא המגובה על ידי המדע